Home NDC 67046-1459 Lamivudine
Product NDC 67046-1459
11-digit product format 670461459
Labeler code 67046
Product ID 67046-1459_2d7daacc-a9ed-2f30-e063-6294a90a4a57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Coupler LLC
Application ANDA090457
Marketing category ANDA
Marketing start 2025-02-06
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 42 .
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 A090457-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 A090457-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19
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 · 84 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 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090457-001 LAMIVUDINE 150MG TABLET / ORAL AB 2018-04-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090457-002 LAMIVUDINE 300MG TABLET / ORAL AB 2018-04-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 67046-1459-3 Lamivudine 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-1459 LAMIVUDINE TABLET, FILM COATED [COUPLER LLC] 1 Current NDC, 1 package rows 20250209_2d7db3b2-9b3c-3031-e063-6294a90a342c.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67046-1459-3 67046145903 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1459-3) 2025-02-06 No No Current