Home NDC 31722-001 lamivudine
Product NDC 31722-001
11-digit product format 317220001
Labeler code 31722
Product ID 31722-001_2b449c4a-56db-0d5f-e063-6394a90ad576
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA211306
Marketing category ANDA
Marketing start 2019-03-21
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 1 .
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 A211306-001 LAMIVUDINE LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211306-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211306-001 LAMIVUDINE 100MG TABLET / ORAL AB 2019-03-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 31722-001-02 lamivudine 20 in 1 CARTON TABLET, FILM COATED 20 3 31722-001-02 lamivudine 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 31722-001-60 lamivudine 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-001 LAMIVUDINE (LAMIVUDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 3 package rows 20250112_e90671c6-7fff-48f4-8898-29f02d049c8b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 31722-001-02 31722000102 20 BLISTER PACK in 1 CARTON (31722-001-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK 20 blister pack 2019-03-21 0000-00-00 No No Current 31722-001-60 31722000160 60 TABLET, FILM COATED in 1 BOTTLE (31722-001-60) 2019-03-21 0000-00-00 No No Current