Application 018482
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROCARDIA | NIFEDIPINE | CAPSULE;ORAL | 10MG | Yes | Yes |
| 002 | PROCARDIA | NIFEDIPINE | CAPSULE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018482-001 | PROCARDIA | NIFEDIPINE | 10MG | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N018482-002 | PROCARDIA | NIFEDIPINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 |
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 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018482-002 | PROCARDIA | 20MG | CAPSULE / ORAL | RLD | 1986-07-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018482-002 | PROCARDIA | 20MG | CAPSULE / ORAL | RLD | 1986-07-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018482-001 | PROCARDIA | 10MG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018482-002 | PROCARDIA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1986-07-24 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018482-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018482-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018482-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018482-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018482-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018482-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018482-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018482-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018482-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018482-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018482-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018482-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018482-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018482-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018482-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018482-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018482-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018482-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018482-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018482-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018482-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018482-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018482-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018482-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018482-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018482-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018482-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018482-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N018482-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N018482-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018482-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018482-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018482-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018482-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N018482-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N018482-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018482-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N018482-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N018482-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018482-001 | 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 |
|---|---|---|---|---|---|---|
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 446505e8-cd68-4037-bebe-954a893dc67b | 2026-02-13 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 3334ab6f-aeb0-4b78-8d17-f0aedd94f996 | 2026-02-11 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | REMEDYREPACK INC. | 24e56333-5601-48fd-a263-f6be90983fb4 | 2026-02-10 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Oceanside Pharmaceuticals | fb6d8f32-198e-4ccf-bf25-069c03d624fd | 2026-02-09 | Warnings, Adverse reactions | NIFEDIPINE |
| nifedipine | NIFEDIPINE | Oceanside Pharmaceuticals | c7874606-c71e-424c-b881-38697988e0d0 | 2026-02-09 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Oceanside Pharmaceuticals | ca5b0178-4e5f-4077-ada5-7058b0a03858 | 2026-02-05 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Upsher-Smith Laboratories, LLC | 160271a8-7922-2107-e054-00144ff88e88 | 2026-01-19 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Upsher-Smith Laboratories, LLC | 3bf4282f-b063-4d35-8ef0-6f48b98e9deb | 2026-01-19 | Warnings, Adverse reactions | NIFEDIPINE |
| nifedipine | NIFEDIPINE | Elite Pharmaceutical Solution, Inc. | 1df07edb-630d-4c70-a68c-bdbc607ce850 | 2026-01-13 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | PD-Rx Pharmaceuticals, Inc. | 7160331a-8735-4bc0-8cb9-a8014512a669 | 2026-01-12 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine ER | NIFEDIPINE | AvPAK | d1a78ff2-7672-3e69-00ef-63d203c80484 | 2026-01-08 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | PD-Rx Pharmaceuticals, Inc. | 89723620-474e-4b16-9f57-4e927efc401c | 2026-01-06 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | PD-Rx Pharmaceuticals, Inc. | 8e5e126a-7da6-4ceb-b72b-5c9dcc7d7769 | 2026-01-06 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 5a7951e7-f507-43e8-9bba-855b79daf170 | 2026-01-06 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f8358be1-848c-d9eb-e053-6294a90a178c | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f2f3564a-d43a-6c36-e053-2a95a90ae878 | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f32c0fc9-b4ad-6a1f-e053-2995a90acf61 | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | da80fa84-9336-082c-e053-2a95a90a8987 | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | d9dec600-4e11-8292-e053-2a95a90a6842 | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | da565525-c77a-0571-e053-2995a90aaa11 | 2026-01-01 | Warnings, Adverse reactions | NIFEDIPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-2600 | Procardia | nifedipine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-2600 | Procardia | nifedipine | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-1004 | nifedipine | nifedipine | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |