Home NDC 0378-4105 Abacavir Sulfate
Product NDC 0378-4105
11-digit product format 003784105
Labeler code 0378
Product ID 0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA091294
Marketing category ANDA
Marketing start 2012-06-19
Substance ABACAVIR SULFATE
Active strength 300 mg/1
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], 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 A091294-001 ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091294-001 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 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091294-001 ABACAVIR SULFATE EQ 300MG BASE TABLET / ORAL AB 2012-06-18 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 Abacavir Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J220T4J9Q2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242679 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 0378-4105-91 Abacavir Sulfate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 12 0378-4105-91 Abacavir Sulfate 1 in 1 CARTON TABLET, FILM COATED 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ABACAVIR ACTIVE MOIETY WR2TIP26VS ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4105 ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250115_5676d391-f9a4-44be-9604-954b3d8d0e2b.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 · 3 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 0378-4105-91 00378410591 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2012-06-19 0000-00-00 No No Current