Nisoldipine
- Product NDC
- 0378-2096
- Requested package NDC
- 0378-2096-01
- 11-digit product format
- 003782096
- Labeler code
- 0378
- Product ID
- 0378-2096_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
- 9 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 package | package | 0378-2096 | 0378-2096-01 | D | Discontinued by firm | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-001 | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-002 | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-003 | NISOLDIPINE | 25.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-01-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-004 | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-01-26 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091001-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091001-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091001-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091001-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091001-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091001-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091001-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091001-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091001-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091001-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091001-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091001-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091001-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091001-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091001-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091001-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091001-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091001-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091001-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091001-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091001-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091001-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091001-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091001-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091001-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091001-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|
| 0378-2096-01 | EA - Each | 0378-2096 | ac365f4a-2465-4866-906f-359c1cbf6acc | 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 |
|---|---|---|---|---|---|---|---|
| 0378-2096-01 | 00378209601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01) | 2011-01-28 | 0000-00-00 | No | No | Current |