Abacavir

Product NDC
0121-0897
11-digit product format
001210897
Labeler code
0121
Product ID
0121-0897_ac38acc1-cc0b-9467-e053-2995a90adf11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA201107
Marketing category
ANDA
Marketing start
2020-08-20
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE
Active strength
20 mg/mL
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
excluded productproduct0121-0897DDiscontinued by firm2026-08-03
excluded packagepackage0121-08970121-0897-20DDiscontinued by firm2026-08-03

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 · 24 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0121-0897-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0121-0897-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0121-0897-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0121-0897-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0121-0897-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0121-0897-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0121-0897-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0121-0897-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0121-0897-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0121-0897-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0121-0897-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-0897-20557ba5c1ecfa…9c80585c8c6e…

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
A201107-001ABACAVIR SULFATEABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201107-001AA

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 UTC2026-02A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-263f01610625f2…
2019-09-15 20:21 UTC2019-09A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201107-001ABACAVIR SULFATEEQ 20MG BASE/MLSOLUTION / ORALAA2016-09-26cb3db0bc1861…

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 UTC2026-02A201107-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201107-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201107-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201107-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201107-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201107-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201107-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201107-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201107-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201107-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201107-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201107-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201107-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201107-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201107-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201107-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201107-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201107-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201107-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201107-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201107-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A201107-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201107-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201107-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201107-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A201107-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201107-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201107-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201107-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201107-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201107-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201107-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201107-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201107-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201107-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201107-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201107-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201107-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201107-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201107-001AA1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0897-15ML - Milliliter0121-0897a1c8a67a-0605-4f54-8149-77084fee32d712021-01-08
0121-0897-20ML - Milliliter0121-089739d741f4-b54d-49cc-8ca3-6683b95b97c812021-01-08

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AbacavirABACAVIRCamber Pharmaceuticals, Inc.e5cbf204-c10d-444b-aba0-180a30645d552017-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201107
application number: ANDA201107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0897-200012108972010 TRAY in 1 CASE (0121-0897-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 1 mL in 1 CUP, UNIT-DOSE (0121-0897-15) 10 tray2020-08-200000-00-00NoNoCurrent