Home NDC 71335-1916 Lamivudine and Zidovudine
Product NDC 71335-1916
11-digit product format 713351916
Labeler code 71335
Product ID 71335-1916_ae1913db-ec19-4f19-9ca8-0c524410de4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine and Zidovudine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090679
Marketing category ANDA
Marketing start 2018-08-30
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 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 A090679-001 LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090679-001 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 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090679-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-08-29 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 71335-1916-1 Lamivudine and Zidovudine 6 in 1 BOTTLE TABLET 6 102 71335-1916-2 Lamivudine and Zidovudine 60 in 1 BOTTLE TABLET 60 102 71335-1916-3 Lamivudine and Zidovudine 4 in 1 BOTTLE TABLET 4 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1916 LAMIVUDINE AND ZIDOVUDINE TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 3 package rows 20240415_61d14a88-9fdf-4373-8360-44ec9e1cd350.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-1916-1 71335191601 6 TABLET in 1 BOTTLE (71335-1916-1) 6 tablet 2021-07-15 0000-00-00 No No Current 71335-1916-2 71335191602 60 TABLET in 1 BOTTLE (71335-1916-2) 60 tablet 2024-04-05 0000-00-00 No No Current 71335-1916-3 71335191603 4 TABLET in 1 BOTTLE (71335-1916-3) 4 tablet 2024-04-05 0000-00-00 No No Current