Home NDC 69097-315 Lamivudine and Zidovudine
Product NDC 69097-315
11-digit product format 690970315
Labeler code 69097
Product ID 69097-315_c360bd83-8e40-4dcf-9d91-1949a99e775c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine and Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA077411
Marketing category ANDA
Marketing start 2018-09-07
Marketing end 0000-00-00
Substance LAMIVUDINE; ZIDOVUDINE
Active strength 150 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077411-001 LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE; ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077411-001 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 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077411-001 LAMIVUDINE AND ZIDOVUDINE 150MG;300MG TABLET / ORAL AB 2018-09-07 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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69097-315-02 2025-12-19 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 69097-315-03 2025-12-19 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 69097-315-15 2025-12-19 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 69097-315-21 2025-12-19 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 69097-315-02 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 69097-315-03 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 69097-315-15 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 69097-315-21 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-315 LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [CIPLA USA INC.] 4 Legacy NDC 20181218_ed84496b-ef83-4af7-a24b-7d9d2d65cf84.zip