Home NDC 60687-720-21 Lamivudine
Product NDC 60687-720
Requested package NDC 60687-720-21
11-digit product format 606870720
Labeler code 60687
Product ID 60687-720_223f034f-e646-cd65-e063-6394a90a3505
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA091606
Marketing category ANDA
Marketing start 2023-01-19
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 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 1 .
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 A091606-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 A091606-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lamivudine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T8Q726O95 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199147 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 60687-720-11 Lamivudine 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 60687-720-21 Lamivudine 30 in 1 CARTON TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-720 LAMIVUDINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 Current NDC, Legacy NDC, 2 package rows 20240919_7ad3a998-8e4d-43a0-8930-8f7a6ae539b4.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LAMIVUDINE LAMIVUDINE Major Pharmaceuticals 6fd4d6b9-65ea-4988-8d6f-dd220ec5052d 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091606 application number: ANDA091606 LAMIVUDINE LAMIVUDINE Golden State Medical Supply, Inc. f3637209-303e-4232-ae79-07315a990973 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091606 application number: ANDA091606 LAMIVUDINE LAMIVUDINE Apotex Corp. 34c02bcc-d6ff-99d4-8e6a-4a91908adca8 2025-09-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091606 application number: ANDA091606 Lamivudine LAMIVUDINE American Health Packaging 7ad3a998-8e4d-43a0-8930-8f7a6ae539b4 2024-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (package): 60687-720-21 ndc (product): 60687-720 ndc11 (package): 60687072021
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 60687-720-21 60687072021 30 BLISTER PACK in 1 CARTON (60687-720-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-720-11) 30 blister pack 2023-01-19 0000-00-00 No No Current