Home NDC 70518-3267 Lamivudine
Product NDC 70518-3267
11-digit product format 705183267
Labeler code 70518
Product ID 70518-3267_d0d8546d-77ec-903c-e053-2a95a90a62ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA090198
Marketing category ANDA
Marketing start 2021-11-13
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 Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3267-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-3267-0 f5e01cc5f278…a2eaf40c39c3…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-3267-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-3267-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-3267-0 557ba5c1ecfa…9c80585c8c6e…
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 A090198-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 A090198-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01
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 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090198-001 LAMIVUDINE 150MG TABLET / ORAL AB 2019-05-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090198-002 LAMIVUDINE 300MG TABLET / ORAL AB 2019-05-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3267 LAMIVUDINE TABLET, FILM COATED [REMEDYREPACK INC.] 5 Legacy NDC 20241226_e3b56bd8-b413-4632-9571-5ad8c4db3bc3.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lamivudine LAMIVUDINE Macleods Pharmaceuticals Limited 1be30bcc-2d9f-4afc-8f09-adc840b3f2d9 2022-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090198 application number: ANDA090198
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-3267-0 70518326700 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3267-0) 2021-11-13 0000-00-00 No No Current