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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 | ||
| unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | ||
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | ||
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | ||
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | ||
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | ||
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | ||
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | ||
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | ||
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | ||
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | ||
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | ||
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | ||
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | ||
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… | ||
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 906f6e251498… | bf70b80e44f0… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… | ||
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… | ||
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8fc7167e32ce… | e96bbc724034… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4184dd79f89f… | 545327b3e20f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… | ||
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 263afe128892… | 91768de4ddbe… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 65862-073 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… | ||
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-073 | 65862-073-18 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077844-001 | ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077844-001 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077844-001 | ABACAVIR SULFATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-12-17 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077844-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077844-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077844-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077844-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077844-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077844-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077844-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077844-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077844-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077844-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077844-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077844-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077844-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077844-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077844-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077844-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077844-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077844-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077844-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077844-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077844-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077844-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077844-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077844-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077844-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077844-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077844-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077844-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077844-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077844-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077844-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077844-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077844-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077844-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077844-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077844-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077844-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077844-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077844-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077844-001 | AB | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Abacavir | ABACAVIR | Major Pharmaceuticals | 4b286ec6-68a7-4ec0-af07-5a27ec9cb35d | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 077844 ANDA077844 |
| Abacavir | ABACAVIR | American Health Packaging | 01e46f58-8bda-4ff3-ab21-57d5b540d440 | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | 077844 ANDA077844 |
| Abacavir | ABACAVIR | Aurobindo Pharma Limited | 5409c8ed-17c3-454f-bb88-d597ba8f84ec | 2024-05-05 | Boxed warning, Warnings, Adverse reactions | 077844 ANDA077844 65862-073 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abacavir
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ABACAVIR SULFATE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J220T4J9Q2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 242679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5409c8ed-17c3-454f-bb88-d597ba8f84ec | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| aaa99659-c62c-7281-d402-9590409850c2 | Product name | 6 | 20260128 |
| 3832141c-c294-474a-9473-1052c891450e | Product name | 2 | 20230105 |
| e1e3cf65-28b8-ebf3-c11f-d11a82e0862a | Product name | 4 | 20180604 |
| af19b329-4f44-cd81-491a-fbb7fe7a079f | Product name | 2 | 20151013 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-073-60 | Abacavir | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-073-60 | EA - Each | 65862-073 | 0230c533-6540-4dc1-9101-f6fe540d57bc | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 242679 | abacavir 300 MG Oral Tablet | PSN | 5409c8ed-17c3-454f-bb88-d597ba8f84ec | 16 |
| 242679 | abacavir 300 MG Oral Tablet | SCD | 5409c8ed-17c3-454f-bb88-d597ba8f84ec | 16 |
| 242679 | abacavir (as abacavir sulfate) 300 MG Oral Tablet | SY | 5409c8ed-17c3-454f-bb88-d597ba8f84ec | 16 |
| 242679 | abacavir 300 MG Oral Tablet | PSN | 01e46f58-8bda-4ff3-ab21-57d5b540d440 | 7 |
| 242679 | abacavir 300 MG Oral Tablet | SCD | 01e46f58-8bda-4ff3-ab21-57d5b540d440 | 7 |
| 242679 | abacavir (as abacavir sulfate) 300 MG Oral Tablet | SY | 01e46f58-8bda-4ff3-ab21-57d5b540d440 | 7 |
| 242679 | abacavir 300 MG Oral Tablet | PSN | 4b286ec6-68a7-4ec0-af07-5a27ec9cb35d | 6 |
| 242679 | abacavir 300 MG Oral Tablet | SCD | 4b286ec6-68a7-4ec0-af07-5a27ec9cb35d | 6 |
| 242679 | abacavir (as abacavir sulfate) 300 MG Oral Tablet | SY | 4b286ec6-68a7-4ec0-af07-5a27ec9cb35d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-073-18 | 65862007318 | 1800 TABLET, FILM COATED in 1 BAG (65862-073-18) | 17-DEC-12 | Current | |||
| 65862-073-60 | 65862007360 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60) | 2012-12-17 | 0000-00-00 | No | No | Current |