Abacavir

Product NDC
65862-073
11-digit product format
658620073
Labeler code
65862
Product ID
65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077844
Marketing category
ANDA
Marketing start
2012-12-17
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-073UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage65862-07365862-073-18UNFINISHEDActive or certified unfinished drug listing2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-073-18a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-073-181d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-073-18390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-073-18e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-073-18bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-073-18f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-073-18f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-073-1868b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-073-1805c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-073-1848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-073-1827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-073-188d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-073-18d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-073-1850b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-073-18906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-073-186db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-073-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-073-184184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-073-184bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-073-18263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-073-185b2001dcd8f5…54b53d4dc9e4…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077844-001ABACAVIR SULFATEABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077844-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077844-001ABACAVIR SULFATEEQ 300MG BASETABLET / ORALAB2012-12-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077844-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077844-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077844-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077844-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077844-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077844-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077844-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077844-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077844-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077844-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077844-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077844-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077844-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077844-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077844-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077844-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077844-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077844-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077844-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077844-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077844-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077844-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077844-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077844-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077844-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077844-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077844-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077844-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077844-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077844-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077844-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077844-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077844-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077844-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077844-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077844-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077844-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077844-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077844-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077844-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Abacavir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABACAVIR SULFATE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J220T4J9Q2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242679Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5409c8ed-17c3-454f-bb88-d597ba8f84ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
3832141c-c294-474a-9473-1052c891450eProduct name220230105
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-073-60Abacavir60 in 1 BOTTLETABLET, FILM COATED6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-073-60EA - Each65862-0730230c533-6540-4dc1-9101-f6fe540d57bc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-073ABACAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 1 package rows20240507_5409c8ed-17c3-454f-bb88-d597ba8f84ec.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AbacavirABACAVIRMajor Pharmaceuticals4b286ec6-68a7-4ec0-af07-5a27ec9cb35d2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077844
application number: ANDA077844
AbacavirABACAVIRAmerican Health Packaging01e46f58-8bda-4ff3-ab21-57d5b540d4402024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077844
application number: ANDA077844
AbacavirABACAVIRAurobindo Pharma Limited5409c8ed-17c3-454f-bb88-d597ba8f84ec2024-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077844
application number: ANDA077844
ndc (product): 65862-073

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSN5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir 300 MG Oral TabletSCD5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir 300 MG Oral TabletPSN01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir 300 MG Oral TabletSCD01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir 300 MG Oral TabletPSN4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6
242679abacavir 300 MG Oral TabletSCD4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-073-18658620073181800 TABLET, FILM COATED in 1 BAG (65862-073-18)17-DEC-12Current
65862-073-606586200736060 TABLET, FILM COATED in 1 BOTTLE (65862-073-60) 2012-12-170000-00-00NoNoCurrent