Home NDC 42385-962 Abacavir and Lamivudine
Product NDC 42385-962
11-digit product format 423850962
Labeler code 42385
Product ID 42385-962_6ce5a446-f6a1-4efe-8a69-fd6ddf1a8ab2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir and Lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA216332
Marketing category ANDA
Marketing start 2022-07-25
Substance ABACAVIR SULFATE; LAMIVUDINE
Active strength 600; 300 mg/1; mg/1
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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 43 .
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 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216332-001 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.
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 2026-09-14 22:38:34 2026-08 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 Abacavir and Lamivudine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 600 mg/1 LAMIVUDINE 300 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42385-962-18 Abacavir and Lamivudine 180 in 1 BOTTLE TABLET, FILM COATED 180 4 42385-962-30 Abacavir and Lamivudine 30 in 1 BOTTLE TABLET, FILM COATED 30 4 42385-962-90 Abacavir and Lamivudine 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-962 ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [LAURUS LABS LIMITED] 3 Current NDC, Legacy NDC, 3 package rows 20241212_d12e80eb-906c-4932-bb03-b4060ba1d31c.zip
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 42385-962-18 42385096218 180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18) 2022-07-25 0000-00-00 No No Current 42385-962-30 42385096230 30 TABLET, FILM COATED in 1 BOTTLE (42385-962-30) 2022-07-25 0000-00-00 No No Current 42385-962-90 42385096290 90 TABLET, FILM COATED in 1 BOTTLE (42385-962-90) 2022-07-25 0000-00-00 No No Current