Full Product Catalog Updated: 5/16/2018 Table of Contents Therapeutic Equivalence Ratings 1 Latex Content 1 Generic Products 2 Specialty Products 173 OTC Products 186 Brand-to-Generic Index 191 With Teva's recent acquisition of Actavis Generics, we provide an even stronger commitment to innovation, quality, and improving people's health around the world. We are pleased to present this combined catalog of all Teva and Actavis products. Actavis products are indicated with an . Customer Service: Tel 800.545.8800 or email [email protected] To view standard business terms, please visit: www.tevagenerics.com/StandardBusinessTerms For updates to our catalog, visit our website at www.tevausa.com/teva-product-catalog PRODUCT CATALOG Therapeutic Equivalence Ratings Drug products the FDA considers therapeutically equivalent to other pharmaceutically equivalent products. These codes are published in FDA’s Orange Book: AA Products in conventional dosage forms not presenting bioequivalence problems AB Products meeting necessary bioequivalence requirements AB1 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading AB2 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading AB3 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading AB4 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading AN Solutions and powders for aerosolization AO Injectable oil solutions AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions AT Topical products BD Products containing active ingredients with known bioequivalence problems and for which adequate studies have not been submitted to FDA demonstrating bioequivalence Latex Content The term “natural rubber” includes all materials made from or containing natural latex. Products containing natural rubber are made using two commonly employed manufacturing processes: the natural rubber latex (NRL) process, and the dry natural rubber (DNR) process. “Natural latex” is defined as a milky fluid that consists of extremely small particles of rubber obtained from plants, principally from the H. brasiliensis (rubber) tree, dispersed in an aqueous medium. It contains a variety of naturally occurring substances including cis-1,4- polyisoprene in a colloidal suspension and plant proteins, which are believed to be the primary allergen. The NRL manufacturing process involves the use of natural latex in a concentrated colloidal suspension. Products are formed from natural rubber latex by dipping, extruding, or coating, and are typically referred to as containing or made of “natural rubber latex.” The DNR manufacturing process involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or by converting the sheets into a solution for dipping. These products are typically referred to as containing or made of dry natural rubber or “crepe” rubber. Examples of products that may contain dry natural rubber include syringe plungers, vial stoppers and injection ports on intra-vascular tubing. For more information from the FDA about natural rubber, please visit www.fda.gov/RegulatoryInformation/Guidances/ucm070925.htm. Based on the information provided by our suppliers, the product listing in this brochure will relate to a specific component of the medical product, its container, or any packaging. Should you have additional questions, please feel free to contact Teva at 888.838.2872. The icons below are used throughout the product sections to identify key product attributes. Indicates products that are preservative free, minimizing the risk of side effects and allergic reactions. Identifies unit dose products and injectable products labeled with a scannable standard code 128 bar code or a scannable standard RSS bar code. Each bar code contains the NDC number for a single tablet, capsule, or a single vial. This feature helps ensure accuracy and patient safety when dispensing, and facilitates order entry and inventory maintenance. 1 GENERIC Strength Description/Imprint Code Size NDC Number PRODUCTS Abacavir and Lamivudine Tablets, USP AB Rated and bioequivalent to Epzicom® Tablets 600 mg/300 mg Capsule-Shaped, Yellow, Film- 30 00093-5382-56 Coated/TV/5382 600 mg/300 mg 600 mg/300 mg Acamprosate Calcium Delayed-Release Tablets AB rated and bioequivalent to Campral® Delayed-Release Tablets 333 mg Round, White to Off-White/77/1140 180 00093-5352-86 333 mg Acetaminophen and Codeine Phosphate Tablets, USP CIII AA Rated to Tylenol® with Codeine Tablets [CIII] 300 mg/15 mg Round, White/TV/50/2 100 00093-0050-01 300 mg/15 mg 300 mg/30 mg 300 mg/30 mg Round, White/TV/150/3 100 00093-0150-01 300 mg/30 mg Round, White/TV/150/3 1000 00093-0150-10 300 mg/60 mg Round, White/93/350/4 100 00093-0350-01 300 mg/60 mg Round, White/93/350/4 500 00093-0350-05 300 mg/60 mg Round, White/93/350/4 1000 00093-0350-10 300 mg/60 mg Acetazolamide Extended-Release Capsules Authorized Generic of Diamox® Sequels 500 mg Orange Opaque/Orange Opaque/barr 513 100 00555-0513-02 500 mg 2 Products not shown actual size. Colors may vary slightly. All trademarks (TM) and registered trademarks (®) are property of their respective companies. GENERIC Strength Description/Imprint Code Size NDC Number PRODUCTS Acitretin Capsules, USP AB Rated and bioequivalent to Soriatane® Capsules 10 mg Light Green Opaque/White 30 00093-1135-56 Opaque/TEVA/1135 10 mg 17.5 mg 17.5 mg Yellow Opaque/TEVA/1138 30 00093-1138-56 25 mg Light Green Opaque/Yellow 30 00093-1136-56 Opaque/TEVA/1136 25 mg Acyclovir Ointment Authorized Generic of Zovirax® Ointment 5% White 30 gm 00591-1159-30 Acyclovir Oral Suspension, USP AB Rated and bioequivalent to Zovirax® Suspension 200 mg/5 mL Off-White, Banana Flavored 473 mL 00472-0082-16 Acyclovir Tablets, USP AB Rated and bioequivalent to Zovirax® Tablets 400 mg Capsule-Shaped, Blue/N943/400 100 00093-8943-01 400 mg 800 mg 400 mg Capsule-Shaped, Blue/N943/400 500 00093-8943-05 800 mg Capsule-Shaped, White to Off- 100 00093-8947-01 White/N947/800 800 mg Capsule-Shaped, White to Off- 500 00093-8947-05 White/N947/800 3 Products not shown actual size. Colors may vary slightly. All trademarks (TM) and registered trademarks (®) are property of their respective companies. GENERIC Strength Description/Imprint Code Size NDC Number PRODUCTS Adapalene and Benzoyl Peroxide Gel AB Rated and bioequivalent to Epiduo® Gel 0.1%/2.5% White to Very Pale Yellow 45 gm 00472-0310-38 Adapalene Gel AB Rated and bioequivalent to Differin® Gel 0.1% 45 gm 00093-6301-95 0.1% 0.3% 45 gm 00472-0126-45 0.3% Adenosine Injection, USP AP Rated to Adenoscan® Injection 3 mg/mL, 60 mg Single-Use Vial 20 mL/Vial 00703-8776-01 3 mg/mL, 90 mg Single-Use Vial 30 mL/Vial 00703-8777-01 The vial and vial stopper are not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F). Do not refrigerate. 4 Products not shown actual size. Colors may vary slightly. All trademarks (TM) and registered trademarks (®) are property of their respective companies. GENERIC Strength Description/Imprint Code Size NDC Number PRODUCTS ADRUCIL® (fluorouracil injection, USP) 50 mg/mL, 500 mg Single-Dose Vial 10 mL/Vial x 10 00703-3015-13† 50 mg/mL, 2.5 gm Pharmacy Bulk Vial 50 mL/Vial x 5 00703-3018-12†† 50 mg/mL, 5 gm Pharmacy Bulk Vial 100 mL/Vial x 5 00703-3019-12†† † Store at 15° to 30°C (59° to 86°F). Protect from light. Retain in carton until use. ††The vial and vial stopper are not made with natural rubber latex. Store at 15° to 30°C (59° to 86°F). Protect from light. Retain in carton until use. Afeditab® CR (Nifedipine Extended-Release Tablets) AB1 Rated and bioequivalent to Adalat® CC Extended Release Tablets 30 mg Round; Film Coated, Brownish Red/ELN30 100 00591-3193-01 30 mg 60 mg 60 mg Round; Film Coated, Brownish Red/ELN60 100 00591-3194-01 60 mg Round; Film Coated, Brownish Red/ELN60 500 00591-3194-05 Albuterol Sulfate Syrup AA Rated to Proventil® Syrup 2 mg/5 mL Clear, Yellow Liquid, Strawberry Flavored 473 mL 00093-0661-16 Albuterol Sulfate Inhalation Solution AN Rated and bioequivalent to Ventolin® and Proventil® Inhalation Solution 0.083% (2.5 mg/3 mL) Colorless to Light Yellow 3 mL x 25 00591-3797-83 0.083% (2.5 mg/3 mL) Colorless to Light Yellow 3 mL x 30 00591-3797-30 0.083% (2.5 mg/3 mL) Colorless to Light Yellow 3 mL x 60 00591-3797-60 Store between 2° to 25° C (36° to 77°F). Protect from light. Store in pouch until time of use. 5 Products not shown actual size. Colors may vary slightly. All trademarks (TM) and registered trademarks (®) are property of their respective companies. GENERIC Strength Description/Imprint Code Size NDC Number PRODUCTS Albuterol Sulfate Syrup AA Rated to Ventolin® Syrup 2 mg/5 mL Clear, Yellow Liquid, Strawberry Flavored 473 mL 00472-0825-16 Alendronate Sodium Tablets, USP AB Rated and bioequivalent to Fosamax® Tablets 35 mg Oval, White to Off-White/AN35 3 x 4 Blister Packs 16252-0599-02 70 mg 35 mg Oval, White to Off-White/AN35 4 x 1 Blister Packs 16252-0599-44 70 mg Oval, White to Off-White/AN70 3 x 4 Blister Packs 16252-0601-02 70 mg Oval, White to Off-White/AN70 4 x 1 Blister Packs 16252-0601-44 Allopurinol Tablets, USP 100 mg Round, White, Scored/DAN/DAN/5543 100 00591-5543-01 100 mg Round, White, Scored/DAN/DAN/5543 1000 00591-5543-10 300 mg Round, Orange, Scored/DAN/DAN/5544 100 00591-5544-01 100 mg 300 mg 300 mg Round, Orange, Scored/DAN/DAN/5544 500 00591-5544-05 Alosetron Hydrochloride Tablets Authorized Generic of Lotronex® Tablets 0.5 mg Oval, White/GX EX1 30 45963-0479-03 0.5 mg 1 mg 1 mg Oval, Blue/GX CT1 30 45963-0480-03 6 Products not shown actual size.