Home NDC 76282-115 Lamivudine and Zidovudine
Product NDC 76282-115
11-digit product format 762820115
Labeler code 76282
Product ID 76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine and Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Exelan Pharmaceuticals Inc.
Application ANDA203259
Marketing category ANDA
Marketing start 2015-04-29
Substance LAMIVUDINE; ZIDOVUDINE
Active strength 150; 300 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203259-001 LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203259-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203259-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2014-02-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lamivudine and Zidovudine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 150 mg/1 ZIDOVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T8Q726O95 Internal UNII lookup 4B9XT59T7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200082 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76282-115-05 Lamivudine and Zidovudine 500 in 1 BOTTLE TABLET, FILM COATED 500 2 76282-115-60 Lamivudine and Zidovudine 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-115 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20190103_4cf565c3-bdec-4c18-93c1-cc7fa8331c90.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lamivudine and Zidovudine LAMIVUDINE AND ZIDOVUDINE Camber Pharmaceuticals, Inc. e816e8f5-1e50-4f49-8bea-92da0121d26e 2026-03-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203259 application number: ANDA203259 LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE XLCare Pharmaceuticals, Inc 55520835-0f24-4e52-af8c-d65841ccaba7 2023-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203259 application number: ANDA203259 Lamivudine and Zidovudine LAMIVUDINE AND ZIDOVUDINE Exelan Pharmaceuticals Inc. 4cf565c3-bdec-4c18-93c1-cc7fa8331c90 2019-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203259 application number: ANDA203259 ndc (product): 76282-115
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76282-115-05 76282011505 500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05) 2015-04-29 0000-00-00 No No Current 76282-115-60 76282011560 60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60) 2015-04-29 0000-00-00 No No Current