Home NDC 60505-3251 LAMIVUDINE
Product NDC 60505-3251
11-digit product format 605053251
Labeler code 60505
Product ID 60505-3251_5383ffc6-2fc3-d9fc-0b98-9a45e7c0276e
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 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091606-001 LAMIVUDINE 150MG TABLET / ORAL AB 2011-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091606-002 LAMIVUDINE 300MG TABLET / ORAL AB 2011-12-02 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LAMIVUDINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 150 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-3251-6 LAMIVUDINE 60 in 1 BOTTLE TABLET, FILM COATED 60 26 60505-3251-8 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 60505-3251 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 · 3 matching rows.
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 60505-3251-6 60505325106 60 TABLET, FILM COATED in 1 BOTTLE (60505-3251-6) 2011-12-02 0000-00-00 No No Current 60505-3251-8 60505325108 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3251-8) 2011-12-02 0000-00-00 No No Current