Home NDC 60505-3250 Lamivudine
Product NDC 60505-3250
11-digit product format 605053250
Labeler code 60505
Product ID 60505-3250_57b50cc9-4140-66b7-ec3c-e10a213dae03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA202941
Marketing category ANDA
Marketing start 2014-01-03
Substance LAMIVUDINE
Active strength 100 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202941-001 LAMIVUDINE LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202941-001 AB
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 2 · 42 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 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB RS 2014-01-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202941-001 LAMIVUDINE 100MG TABLET / ORAL AB 2014-01-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 100 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 205328 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 60505-3250-6 Lamivudine 60 in 1 BOTTLE TABLET, FILM COATED 60 11
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.] 2 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3250 LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.] 10 Current NDC, Legacy NDC, 1 package rows 20240927_87095352-c088-74b1-7be0-d3e293a90611.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 Marketing end Sample Exclude flag Status 60505-3250-6 60505325006 60 TABLET, FILM COATED in 1 BOTTLE (60505-3250-6) 2014-01-03 0000-00-00 No No Current