Home NDC 69097-362 Abacavir and Lamivudine
Product NDC 69097-362
11-digit product format 690970362
Labeler code 69097
Product ID 69097-362_1a48f22b-e37b-4221-9f99-a9e149279630
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abacavir and lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA091144
Marketing category ANDA
Marketing start 2017-03-28
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 2026-12-31
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 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091144-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB RS 2017-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091144-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2017-03-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Abacavir and Lamivudine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 600 mg/1 LAMIVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J220T4J9Q2 Internal UNII lookup 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 602393 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 69097-362-02 Abacavir and Lamivudine 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-362 ABACAVIR AND LAMIVUDINE TABLET, FILM COATED [CIPLA USA INC.] 8 Current NDC, Legacy NDC, 1 package rows 20220125_c0488bee-2f18-4e2e-8e11-68543c023dec.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 69097-362-02 69097036202 30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02) 2017-03-29 0000-00-00 No No Current