Home NDC 60505-3252 LAMIVUDINE
Product NDC 60505-3252
11-digit product format 605053252
Labeler code 60505
Product ID 60505-3252_2cca5476-aba6-0525-0bb5-890f2ca25bb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA091606
Marketing category ANDA
Marketing start 2011-12-02
Substance LAMIVUDINE
Active strength 300 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 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 · 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 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 caaa826d4ba7…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…
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 300 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199147 Internal RxNorm lookup 349491 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 60505-3252-3 LAMIVUDINE 30 in 1 BOTTLE TABLET, FILM COATED 30 26 60505-3252-8 LAMIVUDINE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 Hydroxypropyl Cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 15 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3252 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 25 Current NDC, Legacy NDC, 2 package rows 20240927_34c02bcc-d6ff-99d4-8e6a-4a91908adca8.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 ndc (product): 60505-3252 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-3252-3 60505325203 30 TABLET, FILM COATED in 1 BOTTLE (60505-3252-3) 2011-12-02 0000-00-00 No No Current 60505-3252-8 60505325208 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3252-8) 2011-12-02 0000-00-00 No No Current