Home NDC 31722-739-05 Lamivudine and Zidovudine
Product NDC 31722-739
Requested package NDC 31722-739-05
11-digit product format 317220739
Labeler code 31722
Product ID 31722-739_4cd27be5-81ed-ccb6-e063-6294a90a1798
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine and Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203259
Marketing category ANDA
Marketing start 2014-02-06
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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 31722-739 31722-739-05 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 31722-739 31722-739-05 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 31722-739-05 2026-01-29 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-31 2026-01-29 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-60 2026-01-29 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-05 2021-02-19 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-31 2021-02-19 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-60 2021-02-19 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-05 2020-01-31 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-31 2020-01-31 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997 31722-739-60 2020-01-31 These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-739-05 Lamivudine and Zidovudine 500 in 1 BOTTLE TABLET, FILM COATED 500 7 31722-739-31 Lamivudine and Zidovudine 100 in 1 BLISTER PACK TABLET, FILM COATED 100 7 31722-739-60 Lamivudine and Zidovudine 60 in 1 BOTTLE TABLET, FILM COATED 60 7
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 [CAMBER PHARMACEUTICALS, INC.] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-739 LAMIVUDINE AND ZIDOVUDINE (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20240510_e816e8f5-1e50-4f49-8bea-92da0121d26e.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 ndc (package): 31722-739-05 ndc (product): 31722-739 ndc11 (package): 31722073905 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
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 31722-739-05 31722073905 500 TABLET, FILM COATED in 1 BOTTLE (31722-739-05) 2014-02-06 0000-00-00 No No Current