Home NDC 71335-0639 LAMIVUDINE and ZIDOVUDINE
Product NDC 71335-0639
11-digit product format 713350639
Labeler code 71335
Product ID 71335-0639_aa348cf2-2e1b-486f-9bec-5ccf67879175
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LAMIVUDINE and ZIDOVUDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA079124
Marketing category ANDA
Marketing start 2015-09-18
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 43 .
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 A079124-001 LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079124-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB RS 2015-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079124-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2015-09-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 71335-0639-1 LAMIVUDINE and ZIDOVUDINE 6 in 1 BOTTLE TABLET, FILM COATED 6 5 71335-0639-2 LAMIVUDINE and ZIDOVUDINE 60 in 1 BOTTLE TABLET, FILM COATED 60 5 71335-0639-3 LAMIVUDINE and ZIDOVUDINE 4 in 1 BOTTLE TABLET, FILM COATED 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0639 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 3 package rows 20230331_005f1b9d-1950-4ef3-a9d6-c428a40a3630.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 PD-Rx Pharmaceuticals, Inc. ff62c5fc-965d-4534-a571-a4f290cb9d83 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079124 application number: ANDA079124 LAMIVUDINE and ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE Bryant Ranch Prepack 005f1b9d-1950-4ef3-a9d6-c428a40a3630 2023-03-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079124 application number: ANDA079124 ndc (product): 71335-0639 LAMIVUDINE and ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE Camber Pharmaceuticals, Inc. f80bd0f3-47eb-4b82-a633-4536cf376cf6 2022-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079124 application number: ANDA079124
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 71335-0639-1 71335063901 6 TABLET, FILM COATED in 1 BOTTLE (71335-0639-1) 2021-04-02 0000-00-00 No No Current 71335-0639-2 71335063902 60 TABLET, FILM COATED in 1 BOTTLE (71335-0639-2) 2021-12-27 0000-00-00 No No Current 71335-0639-3 71335063903 4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3) 2021-12-27 0000-00-00 No No Current