Home NDC 31722-754 Lamivudine
Product NDC 31722-754
11-digit product format 317220754
Labeler code 31722
Product ID 31722-754_2b44b10b-132c-4593-e063-6294a90a3ffd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203277
Marketing category ANDA
Marketing start 2014-01-06
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 A203277-001 LAMIVUDINE LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 A203277-002 LAMIVUDINE LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06
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 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203277-001 LAMIVUDINE 150MG TABLET / ORAL AB 2014-01-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203277-002 LAMIVUDINE 300MG TABLET / ORAL AB 2014-01-06 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 31722-754-06 Lamivudine 600 in 1 BOTTLE TABLET, FILM COATED 600 8 31722-754-30 Lamivudine 30 in 1 BOTTLE TABLET, FILM COATED 30 8 31722-754-31 Lamivudine 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 31722-754-32 Lamivudine 100 in 1 CARTON TABLET, FILM COATED 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 ISOMALT INACTIVE INGREDIENT S870P55O2W LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 METHYLENE CHLORIDE INACTIVE INGREDIENT 588X2YUY0A LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 3 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 ISOMALT INACTIVE INGREDIENT S870P55O2W LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 METHYLENE CHLORIDE INACTIVE INGREDIENT 588X2YUY0A LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LAMIVUDINE TABLET, FILM COATED [AVPAK] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LAMIVUDINE TABLET, FILM COATED [AVPAK] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-754 LAMIVUDINE (LAMIVUDINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20250112_49d53e74-3798-4463-b817-1c8beb755034.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 Marketing start Marketing end Sample Exclude flag Status 31722-754-06 31722075406 600 TABLET, FILM COATED in 1 BOTTLE (31722-754-06) 2014-01-06 0000-00-00 No No Current 31722-754-30 31722075430 30 TABLET, FILM COATED in 1 BOTTLE (31722-754-30) 2014-01-06 0000-00-00 No No Current 31722-754-31 31722075431 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-754-31) 2014-01-06 0000-00-00 No No Current 31722-754-32 31722075432 100 TABLET, FILM COATED in 1 CARTON (31722-754-32) 2014-01-06 0000-00-00 No No Current