Ezetimibe and Simvastatin
- Product NDC
- 45963-565
- 11-digit product format
- 459630565
- Labeler code
- 45963
- Product ID
- 45963-565_ea5eedea-08bf-4180-8119-ed74e6365fae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe and Simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA202968
- Marketing category
- ANDA
- Marketing start
- 2017-04-26
- Marketing end
- 0000-00-00
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 45963-565 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 45963-565 | 45963-565-08 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 45963-565 | 45963-565-30 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 | 45963-565 | 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 | 45963-565 | 45963-565-00 | 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 |
|---|---|---|---|---|---|---|---|
| A202968-001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET / ORAL | 2017-04-26 | ||
| A202968-002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET / ORAL | 2017-04-26 | ||
| A202968-003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET / ORAL | 2017-04-26 | ||
| A202968-004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET / ORAL | 2017-04-26 |
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 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-001 | EZETIMIBE AND SIMVASTATIN | 10MG;10MG | TABLET / ORAL | AB | 2017-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-002 | EZETIMIBE AND SIMVASTATIN | 10MG;20MG | TABLET / ORAL | AB | 2017-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-003 | EZETIMIBE AND SIMVASTATIN | 10MG;40MG | TABLET / ORAL | AB | 2017-04-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-004 | EZETIMIBE AND SIMVASTATIN | 10MG;80MG | TABLET / ORAL | AB | 2017-04-26 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202968-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202968-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202968-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202968-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202968-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202968-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202968-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202968-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202968-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202968-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202968-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45963-565-08 | EA - Each | 45963-565 | 02ac9d92-c725-4e12-a5eb-f69eb0a89e6f | 1 | 2017-05-03 |
| 45963-565-30 | EA - Each | 45963-565 | fa37a241-8cc9-4bed-ad52-ded37ffd5795 | 1 | 2017-05-03 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45963-565-08 | 45963056508 | 90 TABLET in 1 BOTTLE (45963-565-08) | 90 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |
| 45963-565-30 | 45963056530 | 30 TABLET in 1 BOTTLE (45963-565-30) | 30 tablet | 2017-04-26 | 0000-00-00 | No | No | Current |