Nisoldipine
- Product NDC
- 0378-2097
- 11-digit product format
- 003782097
- Labeler code
- 0378
- Product ID
- 0378-2097_18276df2-9ea6-4560-b8fc-18b0d8025342
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nisoldipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA091001
- Marketing category
- ANDA
- Marketing start
- 2011-01-28
- Marketing end
- 0000-00-00
- Substance
- NISOLDIPINE
- Active strength
- 17 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0378-2097 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 0378-2097 | 0378-2097-01 | D | Discontinued by firm | 2026-10-16 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091001-001 | NISOLDIPINE | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | ||
| A091001-002 | NISOLDIPINE | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | ||
| A091001-003 | NISOLDIPINE | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | ||
| A091001-004 | NISOLDIPINE | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A091001-004 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091001-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091001-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091001-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091001-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A091001-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A091001-004 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091001-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A091001-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A091001-004 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091001-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091001-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091001-004 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091001-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091001-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091001-004 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091001-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091001-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091001-004 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091001-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091001-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091001-004 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091001-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A091001-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A091001-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091001-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A091001-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A091001-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091001-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091001-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091001-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091001-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A091001-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A091001-004 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A091001-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A091001-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A091001-004 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091001-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091001-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091001-004 | AB | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-2097-01 | EA - Each | 0378-2097 | 0e339b9f-aabb-4f4d-bebf-6a90a791a440 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-2097-01 | 00378209701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01) | 2011-01-28 | 0000-00-00 | No | No | Current |