Home NDC 69097-166-03 LAMIVUDINE
Product NDC 69097-166
Requested package NDC 69097-166-03
11-digit product format 690970166
Labeler code 69097
Product ID 69097-166_65d03051-a84c-49d7-928b-515cb1769bec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LAMIVUDINE
Dosage form TABLET
Route ORAL
Labeler Cipla USA Inc.
Application ANDA077221
Marketing category ANDA
Marketing start 2017-03-03
Marketing end 0000-00-00
Substance LAMIVUDINE
Active strength 150 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]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077221-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 A077221-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077221-001 LAMIVUDINE 150MG TABLET / ORAL AB 2017-03-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077221-002 LAMIVUDINE 300MG TABLET / ORAL AB 2017-03-03 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-166 LAMIVUDINE TABLET [CIPLA USA INC.] 9 Legacy NDC 20190610_36b83d9a-962f-4821-bf44-0bace705b620.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-166-03 69097016603 60 TABLET in 1 BOTTLE (69097-166-03) 60 tablet 2017-03-03 0000-00-00 No No Current