Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

00009-0253-02 6 DEPO-TESTADIOL 10 ML 1 VIAL , INC

00032-1023-01 5 ESTRATESTH.S. SOLVAY PHARMACEUTICALS, INC.

00032-1026-01 5 Estratest SOLVAY PHARMACEUTICALS, INC.

00032-1026-10 5 Estratest SOLVAY PHARMACEUTICALS, INC.

00064-3900-30 6 XENADERM RX HEALTHPOINT, LTD.

00064-3900-60 6 XENADERM RX HEALTHPOINT, LTD.

00143-1140-51 5 BELLADONNA, ALKALOIDS WEST-WARD PHARMACEUTICAL CORP W/PHENOBARBITAL TABLET

00143-1140-10 5 BELLADONNA, ALKALOIDS WEST-WARD PHARMACEUTICAL CORP W/PHENOBARBITAL TABLET

00182-0874-48 5 VIOFORM-HC OINT GOLDLINE LABORATORIES, INC.

00182-1427-23 6 TRIMETHOBENZAMIDE GOLDLINE LABORATORIES, INC. SUPPOSITORIES 200MG 10

00182-1427-19 6 TRIMETHOBENZAMIDE GOLDLINE LABORATORIES, INC. SUPPOSITORIES 200MG 10

00182-7038-11 5 HYDROCORTISONE HEMORRHOIDAL GOLDLINE LABORATORIES, INC. SUPP 25MG 12

00187-4100-10 5 LIBRAX 2.5-5 MG 100 CAPSULES VALEANT PHARMACEUTICALS NORTH AMERICA

00245-0111-12 5 HEMRIL-HC UPSHER-SMITH LABORATORIES, INC.

00245-0112-12 5 HEMRIL 30 UPSHER-SMITH LABORATORIES, INC.

00245-0112-24 5 HEMRIL 30 UPSHER-SMITH LABORATORIES, INC.

00277-0185-41 5 DONATUSSIN SYRUP LASER PHARMACEUTICALS, LLC

00472-0511-12 5 HEMORRHOIDAL HC SUPPOSITORIES 25 MG

00472-0511-24 5 HEMORRHOIDAL HC SUPPOSITORIES ACTAVIS 25 MG

00472-0650-16 5 ENTAC LIQUID ACTAVIS

00472-0801-16 5 NALDELATE SYRUP ACTAVIS

00472-0809-31 5 NALDELATE PEDIATRIC DROPS ACTAVIS

00472-1007-16 5 NALDELATE PEDIATRIC SYRUP ACTAVIS

Thursday, November 08, 2007 Page 1 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

00472-1007-04 5 NALDELATE PEDIATRIC SYRUP ACTAVIS

00496-0716-04 5 PRAMOSONE CREAM 1% FERNDALE LABORATORIES INC.

00496-0716-03 5 PRAMOSONE CREAM 1% FERNDALE LABORATORIES INC.

00496-0717-03 5 PRAMOSONE CREAM 2.5% FERNDALE LABORATORIES INC.

00496-0717-04 5 PRAMOSONE CREAM 2.5% FERNDALE LABORATORIES INC.

00496-0726-04 5 PRAMOSONE LOTION 2.5% FERNDALE LABORATORIES INC.

00496-0726-06 5 PRAMOSONE LOTION 2.5% FERNDALE LABORATORIES INC.

00496-0729-03 5 PRAMOSONE LOTION 1% FERNDALE LABORATORIES INC.

00496-0729-06 5 PRAMOSONE LOTION 1% FERNDALE LABORATORIES INC.

00496-0729-04 5 PRAMOSONE LOTION 1% FERNDALE LABORATORIES INC.

00496-0763-04 5 PRAMOSONE OINTMENT 1% FERNDALE LABORATORIES INC.

00496-0777-04 5 PRAMOSONE OINTMENT 2.5% FERNDALE LABORATORIES INC.

00496-0778-64 5 ANALPRAM HC CREAM 1% SINGLES FERNDALE LABORATORIES INC.

00496-0778-04 5 ANALPRAM HC CREAM 1% FERNDALE LABORATORIES INC.

00496-0778-74 5 Analpram HC Cream 1% 1 X 4g tube FERNDALE LABORATORIES INC.

00496-0778-65 5 Analpram HC Cream 1% 12 X 4g tube FERNDALE LABORATORIES INC.

00496-0800-64 5 ANALPRAM HC 2.5% CREAM SINGLES FERNDALE LABORATORIES INC.

00496-0800-04 5 ANALPRAM HC CREAM 2.5% FERNDALE LABORATORIES INC.

00496-0800-74 5 Analpram HC Cream 2.5% 1 x 4g tube FERNDALE LABORATORIES INC.

00496-0800-65 5 Analpram HC Cream 2.5% 30 X 4g tube FERNDALE LABORATORIES INC.

00527-1409-01 5 METHYLTESTOSTERONE AND LANNETT COMPANY, INC. ESTERIFIED ESTROGENS 1.25MG

00527-1410-10 5 METHYLTESTOSTERONE AND LANNETT COMPANY, INC. ESTERIFIED ESTROGENS TAB 2.5MG

00527-1410-01 5 METHYLTESTOSTERONE AND LANNETT COMPANY, INC. ESTERIFIED ESTROGENS TAB 2.5MG

00555-0364-02 5 DURADRIN CAP 65/100/325MG C4 BARR LABORATORIES INC

00574-7090-12 5 HYDROCORTISONE ACETATE PADDOCK LABORATORIES, INC. SUPPOSITORIES 25 MG 12 UD

Thursday, November 08, 2007 Page 2 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

00574-7093-12 5 ENCORT PADDOCK LABORATORIES, INC.

00574-7220-10 6 TRIMETHOBENZAMIDE PADDOCK LABORATORIES, INC. SUPPOSITORIES

00574-7222-10 6 TRIMETHOBENZAMIDE PADDOCK LABORATORIES, INC. SUPPOSITORIES

00574-7222-50 6 TRIMETHOBENZAMIDE PADDOCK LABORATORIES, INC. SUPPOSITORIES 200 MG 50 UD

00603-1030-58 5 BELLADONNA ALKA/PB ELIX PHARMACEUTICALS, INC.

00603-1270-54 6 GRANUL-DERM AERO QUALITEST PHARMACEUTICALS, INC.

00603-2418-32 5 BELLADONNA ALK/PB TABLET QUALITEST PHARMACEUTICALS, INC.

00603-2418-21 5 BELLADONNA ALK/PB TAB 100 QUALITEST PHARMACEUTICALS, INC.

00603-2419-21 5 BELLATAL ER TAB 100 QUALITEST PHARMACEUTICALS, INC.

00603-2423-21 5 BELLASPAS TAB 100 QUALITEST PHARMACEUTICALS, INC.

00603-2423-28 5 BELLASPAS TAB 500 QUALITEST PHARMACEUTICALS, INC.

00603-2714-32 5 CHLORDIAZEPOXIDE/CLIDINIUM QUALITEST PHARMACEUTICALS, INC. CAPSULES

00603-2714-21 5 CHLORDIAZEPOXIDE/CLIDINIUM CAP QUALITEST PHARMACEUTICALS, INC.

00603-4424-21 5 MEPERIDINE/PROMETHAZINE 50 MG/25 QUALITEST PHARMACEUTICALS, INC. MG CAPSULE

00603-4664-24 5 MIGQUIN CAPSULES QUALITEST PHARMACEUTICALS, INC.

00603-4664-21 5 MIGQUIN CAP QUALITEST PHARMACEUTICALS, INC.

00603-7495-39 5 ZOLENE HC QUALITEST PHARMACEUTICALS, INC.

00603-7496-39 5 ZOCORT HC AQUEOUS SOLN 10 ML QUALITEST PHARMACEUTICALS, INC.

00603-7801-76 5 IODOCHLORHYDROXYQUIN /H QUALITEST PHARMACEUTICALS, INC.

00603-8127-11 5 HEMORRHOIDAL HC SUPP QUALITEST PHARMACEUTICALS, INC.

00603-8127-18 5 HEMORRHOIDAL HC QUALITEST PHARMACEUTICALS, INC.

00642-0012-15 5 CORTIC-ND EAR DROPS EVERETT LABORATORIES, INC.

00677-1247-01 5 CHLORDIAZEPOXIDE 5MG WITH UNITED RESEARCH LABORATORIES CLIDINIUM BROMIDE 2.5MG

00677-1739-01 5 ISOMETHEP/SICHLOR/ APPAP CAP UNITED RESEARCH LABORATORIES

00677-1900-33 5 CARBETA 20/PHENY 15/GUAIF 100 LQ UNITED RESEARCH LABORATORIES PT

Thursday, November 08, 2007 Page 3 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

00677-1900-41 5 CARBETA 20/PHENY 15/GIAF 100 LQ UNITED RESEARCH LABORATORIES 4OZ

00682-9080-15 5 OTOMAR-HC EAR DROPS MARNEL PHARMACEUTICAL, INC.

00713-0107-09 6 TRIMETHOBENZAMIDE HCL 100MG G&W LABORATORIES, INC SUPPOSITORY

00713-0108-50 6 TRIMETHOBENZAMIDE HCL 200MG G&W LABORATORIES, INC SUPPOSITORY

00713-0108-09 6 TRIMETHOBENZAMIDE HCL 200MG G&W LABORATORIES, INC SUPPOSITORY

00713-0503-24 5 HYDROCORTISONE ACETATE 25MG G&W LABORATORIES, INC SUPPOSITORY

00713-0503-12 5 HYDROCORTISONE ACETATE 25MG G&W LABORATORIES, INC SUPPOSITORY

00713-0503-01 5 HYDROCORTISONE ACETATE 25MG G&W LABORATORIES, INC SUPPOSITORY

00781-1406-01 6 NYLIDRIN 6MG SANDOZ

00781-1840-01 5 ISOXSUPRINE 10MG 100TB BT SANDOZ

00781-1840-13 5 ISOXSUPRINE 10MG SANDOZ

00781-1842-01 5 ISOXSUPRINE 20MG 100TB BT SANDOZ

00781-1842-13 5 ISOXSUPRINE 20MG SANDOZ

00781-1988-01 6 T.E.H. TABLETS SANDOZ

00781-7700-40 5 HEMORRHOIDAL HC 25MG SUP SANDOZ

00781-7700-32 5 HEMORRHOIDAL HC 25MG SUP SANDOZ

00813-0393-11 5 TRI-OTIC PHARMICS INC.

00904-0160-12 5 HYDROCORTISONE ACETATE MAJOR PHARMACEUTICALS

00904-2548-60 6 BELLAMINE MAJOR PHARMACEUTICALS

00904-2735-15 5 TEGAMIDE 100MG SUPP MAJOR PHARMACEUTICALS

00904-2736-15 5 TEGAMIDE 200MG SUPP MAJOR PHARMACEUTICALS

00904-7622-60 5 MIGRATINE CAPSULE MAJOR PHARMACEUTICALS

10956-0725-08 5 ADULT COLD MEDICINE THE REESE CHEMICAL COMPANY

10956-0725-04 5 ADULT COLD MEDICINE THE REESE CHEMICAL COMPANY

11528-0010-01 5 Covaryx CENTRIX PHARMACEUTICAL, INC.

Thursday, November 08, 2007 Page 4 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

11528-0020-01 5 Covaryx HS CENTRIX PHARMACEUTICAL, INC.

11528-0200-98 5 ERGOCAFF PB CENTRIX PHARMACEUTICAL, INC.

12830-0781-10 5 OTOZONE R.A. MCNEIL COMPANY

12830-0781-12 5 OTOZONE R.A. MCNEIL COMPANY

13279-0104-30 6 AllanDerm-T 30gm ALLAN PHARMACEUTICAL, L.L.C.

13279-0104-60 6 ALLANDERM-T OINTMENT 60GM ALLAN PHARMACEUTICAL, L.L.C.

14508-0304-08 5 MIDRIN CAPSULES SUN PHARMACEUTICAL INDUSTRIES, INC.

16781-0116-95 6 OPTASE ONSET THERAPEUTICS

45802-0723-32 6 TRIMETHO 100MG (CHLD) 50'S PHARMACEUTICALS

45802-0723-90 6 TRIMETHO SUPP 100MG CHILD PERRIGO PHARMACEUTICALS

45802-0724-32 6 TRIMETH 200MG SUP (ADULT) 50'S PERRIGO PHARMACEUTICALS

45802-0724-90 6 TRIMETH 200 MG SUP (ADULT) 10'S PERRIGO PHARMACEUTICALS

45802-0725-33 5 HC ACETATE 25MG SUPP 100 PERRIGO PHARMACEUTICALS

45802-0725-31 5 HC ACETATE SUPP 25 MG PERRIGO PHARMACEUTICALS

45802-0725-30 5 HC ACETATE SUPP 25MG PERRIGO PHARMACEUTICALS

45802-0806-01 5 SALICYLIC ACID CREAM, 6% PERRIGO PHARMACEUTICALS

45802-0818-41 5 SALICYLIIC ACID LOTION, 6% PERRIGO PHARMACEUTICALS

46672-0608-16 5 FENTEX LIQUID MIKART INC.

50991-0101-01 5 POLY HIST FORTE TABLETS POLY PHARMACEUTICAL CO., INC.

51079-0621-81 6 GRANULEX 2 OZ (56.7 G) UDL LABORATORIES, INC.

51079-0621-82 6 GRANULEX 4 OZ (113.4 G) UDL LABORATORIES, INC.

51674-0116-01 5 CORTANE B-OTIC BLANSETT PHARMACAL CO., INC.

51674-0117-02 5 CBO LOTION BLANSETT PHARMACAL CO., INC.

51674-0118-01 5 CBO AQUEOUS DROPS BLANSETT PHARMACAL CO., INC.

51991-0078-01 5 E.E.M.T. H.S. TABLETS BRECKENRIDGE PHARMACEUTICAL, INC.

51991-0079-01 5 E.E.M.T. D.S. TABLETS BRECKENRIDGE PHARMACEUTICAL, INC.

51991-0124-22 6 TRYPSIN COMPLEX OINTMENT BRECKENRIDGE PHARMACEUTICAL, INC.

Thursday, November 08, 2007 Page 5 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

51991-0671-71 5 OTIRX SOLUTION BRECKENRIDGE PHARMACEUTICAL, INC.

52152-0009-02 5 ISOXSUPRINE TAB 10MG(100) ACTAVIS INC.

52152-0009-05 5 ISOXSUPRINE HCL 10MG ACTAVIS INC.

52152-0010-02 5 ISOXSUPRINE TAB 20MG(100) ACTAVIS INC.

52152-0010-05 5 ISOXSUPRINE HCL 20MG ACTAVIS INC.

52152-0010-04 5 ISOXSUPRINE HCL 20MG ACTAVIS INC.

52152-0018-02 5 CHLORDIAZ W/CLID BR (100) ACTAVIS INC.

52152-0018-05 5 CHLORDIAZ W/CLID BR(1000) ACTAVIS INC.

52152-0018-04 5 CHLORDIAZ W/CLID BR (500) ACTAVIS INC.

52152-0115-05 6 BELLAMINE S TABLETS ACTAVIS INC.

52152-0115-02 6 BELLAMINE S TAB (100) ACTAVIS INC.

52152-0190-02 6 MEPERIDINE/PROMETHAZINE CAPS CII ACTAVIS INC.

53706-1001-01 6 TBC DELTA PHARMACEUTICALS, INC.

53706-1001-02 6 TBC DELTA PHARMACEUTICALS, INC.

54859-0502-06 5 TUSNEL LIQUID LLORENS PHARMACEUTICALS INT'L DIVISION

58177-0027-04 5 MEPERIDINE HCI AND PROMETHAZINE ETHEX CORPORATION HCI

59630-0135-01 5 ZOTO-HC EAR DROPS SCIELE PHARMA, INC.

60258-0425-16 5 PULMARI-GP SYRUP CYPRESS PHARMACEUTICAL, LLC

60258-0429-16 5 BROMHIST PDX SYRUP CYPRESS PHARMACEUTICAL, LLC

60258-0451-10 5 CYOTIC DROPS CYPRESS PHARMACEUTICAL, LLC

60432-0009-16 5 ANTISPASMODIC ELIXIR MORTON GROVE PHARMACEUTICALS, INC

60432-0009-04 5 ANTISPASMODIC ELIXIR MORTON GROVE PHARMACEUTICALS, INC

61570-0303-61 5 ANUSOL-HC SUPPOSITORIES MONARCH PHARMACEUTICALS, INC.

61570-0303-62 5 ANUSOL-HC SUPPOSITORIES MONARCH PHARMACEUTICALS, INC.

61570-0504-50 5 TIGAN 200MG SUPPOSITORIES MONARCH PHARMACEUTICALS, INC.

Thursday, November 08, 2007 Page 6 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

61570-0504-10 5 TIGAN SUPPOSITORIES MONARCH PHARMACEUTICALS, INC.

62584-0139-01 5 EPIDRIN 65/100/325 100UD AMERICAN HEALTH PACKAGING

62794-0002-50 6 GRANULEX TOPICAL SPRAY BERTEK PHARMACEUTICALS, INC.

62794-0002-51 6 GRANULEX TOPICAL SPRAY MYLAN BERTEK PHARMACEUTICALS, INC.

63304-0408-12 5 PROCTOSOL HC 25MG RANBAXY PHARMACEUTICALS, INC. SUPPOSITORIES x 12

63304-0408-24 5 PROCTOSOL HC 25MG RANBAXY PHARMACEUTICALS, INC. SUPPOSITORIES x 24

64125-0101-01 5 ISOMETHEPTENE EXCELLIUM PHARMACEUTICAL, INC. MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN CAPSULES

64125-0101-02 5 ISOMETHEPTENE EXCELLIUM PHARMACEUTICAL, INC. MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN CAPSULES

64125-0128-10 5 BELLADONNA ALKALOIDS WITH EXCELLIUM PHARMACEUTICAL, INC. PHENOBARBITAL TABLETS

65162-0530-86 5 A-TAN 12X SUSPENSION AKYMA PHARMACEUTICALS LLC

65649-0411-24 5 ANUSOL-HC 25MG SUPPOSITORY 24'S , INC.

65649-0411-12 5 ANUSOL-HC 25MG SUPPOSITORY 12'S SALIX PHARMACEUTICALS, INC.

65649-0511-24 5 PROCTOCORT 30MG SUPPOSITORY SALIX PHARMACEUTICALS, INC. 24'S

65649-0511-12 5 PROCTOCORT 30MG SUPPOSITORY SALIX PHARMACEUTICALS, INC. 12'S

66213-0421-50 5 DONNATAL EXTENTABS 500'S PBM PHARMACEUTICALS, INC.

66213-0421-10 5 DONNATAL EXTENTABS 100'S PBM PHARMACEUTICALS, INC.

66213-0423-16 5 DONNATAL GRAPE ELIXIR, 16OZ PBM PHARMACEUTICALS, INC.

66213-0423-04 5 DONNATAL GRAPE ELIXIR, 4OZ PBM PHARMACEUTICALS, INC.

66213-0425-11 5 DONNATAL TABLETS 1000'S PBM PHARMACEUTICALS, INC.

66213-0425-10 5 DONNATAL TABLETS 100'S PBM PHARMACEUTICALS, INC.

66346-0181-65 5 ACCUHIST PDX SYRUP PEDIAMED PHARMACEUTICALS, INC.

66663-0112-01 5 MIGRATEN PHARMELLE, LLC

66992-0120-16 5 BETAVENT SYRUP WRASER PHARMACEUTICALS

66993-0601-02 5 MIGRIN-A CAPSULES 325/65/100MG 100 PRASCO LABORATORIES

Thursday, November 08, 2007 Page 7 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

66993-0915-61 5 Revina NLT 90 USP..., 60g PRASCO LABORATORIES

66993-0920-02 5 ESSIAN TABLETS 1.25/2.5MG, 100 PRASCO LABORATORIES

66993-0921-02 5 ESSIAN HS TABLETS .625/1.25MG, 100 PRASCO LABORATORIES

68040-0702-13 5 ALCORTIN PRIMUS PHARMACEUTICALS, INC.

68040-0704-26 5 NOVACORT PRIMUS PHARMACEUTICALS, INC.

68047-0190-16 5 DROTUSS LARKEN LABORATORIES, INC.

68453-0410-10 5 LIBRAX CAPSULES VICTORY PHARMA, INC

68462-0105-30 5 Ondansetron Hydrochloride Tablets 4mg GLENMARK PHARMACEUTICALS, INC., 30's USA

68462-0106-30 5 Ondansetron Hydrochloride Tablets 8mg GLENMARK PHARMACEUTICALS, INC., USA

68462-0162-05 5 Carvedilol Tablets 3.125mg 500's GLENMARK PHARMACEUTICALS, INC., USA

68462-0162-01 5 Carvedilol Tablets 3.125mg 100's GLENMARK PHARMACEUTICALS, INC., USA

68462-0163-05 5 Carvedilol Tablets 6.25mg 500's GLENMARK PHARMACEUTICALS, INC., USA

68462-0163-01 5 Carvedilol Tablets 6.25mg 100's GLENMARK PHARMACEUTICALS, INC., USA

68462-0164-05 5 Carvedilol Tablets 12.5mg 500's GLENMARK PHARMACEUTICALS, INC., USA

68462-0164-01 5 Carvedilol Tablets 12.5mg 100's GLENMARK PHARMACEUTICALS, INC., USA

68462-0165-05 5 Carvedilol Tablets 25mg 500's GLENMARK PHARMACEUTICALS, INC., USA

68462-0165-01 5 Carvedilol Tablets 25mg 100's GLENMARK PHARMACEUTICALS, INC., USA

68462-0173-01 5 ESTERIFIED ESTGN .625MG W/MTHYLT GLENMARK PHARMACEUTICALS, INC., 1.25MG HS USA

68462-0174-01 5 ESTERIFIED ESTGN 1.25MG W/MTHYLT GLENMARK PHARMACEUTICALS, INC., 2.5MG DS USA

68462-0178-01 5 Naproxen Sodium Tablets 275mg GLENMARK PHARMACEUTICALS, INC., USA

68462-0179-01 5 Naproxen Sodium Tablets 550mg GLENMARK PHARMACEUTICALS, INC., USA

Thursday, November 08, 2007 Page 8 of 9 Listing of NDCs where Desi Indicator Value is either 5 (LTE/IRS) OR 6 (LTE/IRS & Withdrawn from Market) For Active Products and Active Labelers

NDC DESI PRODUCT NAME LABELER NAME

# of DESI = 5 RECORDS: 163

# of DESI = 6 RECORDS: 32

TOTAL RECORDS: 195

Thursday, November 08, 2007 Page 9 of 9