Nifedipine
- Product NDC
- 0904-7080
- Requested package NDC
- 0904-7080-06
- 11-digit product format
- 009047080
- Labeler code
- 0904
- Product ID
- 0904-7080_104876d9-0312-4f12-9324-76da4a8663a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA210614
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- Marketing end
- 2022-09-30
- Substance
- NIFEDIPINE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0904-7080 | 0904-7080-06 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210614-001 | NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | |
| A210614-002 | NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | |
| A210614-003 | NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | RS | 2019-03-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210614-001 | AB2 |
| A210614-002 | AB2 |
| A210614-003 | AB2 |
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 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210614-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2019-03-12 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210614-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210614-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210614-003 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210614-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210614-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210614-003 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210614-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210614-003 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210614-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210614-003 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210614-003 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-002 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210614-003 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210614-003 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-002 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210614-003 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210614-003 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210614-001 | AB2 | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bbd94e90-e531-9113-45c1-29860f331640 | Product name | 7 | 20230104 |
| 5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd | Product name | 4 | 20220126 |
| 308fd2ea-d88a-e021-96c1-7c2ab74d6e4b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7080-06 | Nifedipine | 50 in 1 CARTON | TABLET, EXTENDED RELEASE | 50 | 6 | |
| 0904-7080-06 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 6 | |
| 0904-7080-61 | Nifedipine | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | 6 | |
| 0904-7080-61 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7080-06 | EA - Each | 0904-7080 | 1f4ea3e5-22cd-4a64-8c1f-1114fbefb4d4 | 1 | 2021-04-08 |
| 0904-7080-61 | EA - Each | 0904-7080 | b80de5b1-1e11-40ac-9796-65cadfee4d32 | 1 | 2021-04-08 |
DailyMed Dashboard NDC Coverage#
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 | St. Mary's Medical Park Pharmacy | 1add684f-d082-72cc-e063-6394a90a1214 | 2026-06-29 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | St. Mary's Medical Park Pharmacy | 1ab8945b-bea5-9827-e063-6294a90af334 | 2026-06-17 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | e1cd5011-b80e-4b1b-8729-56260b8b3c26 | 2026-05-15 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Coupler LLC | 518d39af-0be1-acbc-e063-6294a90a4ada | 2026-05-11 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Major Pharmaceuticals | 41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9 | 2026-04-30 | Warnings, Adverse reactions | 210614 ANDA210614 0904-7080-06 0904-7080 00904708006 |
| Nifedipine | NIFEDIPINE | Ingenus Pharmaceuticals, LLC | 4d3e11d2-d320-45d3-96c8-48322202b504 | 2026-03-30 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Cardinal Health 107, LLC | c98ecf77-ae9a-438b-9bad-ffbed25d95bc | 2026-02-16 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 446505e8-cd68-4037-bebe-954a893dc67b | 2026-02-13 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 3334ab6f-aeb0-4b78-8d17-f0aedd94f996 | 2026-02-11 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | REMEDYREPACK INC. | 24e56333-5601-48fd-a263-f6be90983fb4 | 2026-02-10 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f8358be1-848c-d9eb-e053-6294a90a178c | 2026-01-01 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f2f3564a-d43a-6c36-e053-2a95a90ae878 | 2026-01-01 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | f32c0fc9-b4ad-6a1f-e053-2995a90acf61 | 2026-01-01 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | A-S Medication Solutions | 9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd44 | 2025-12-16 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Preferred Pharmaceuticals Inc. | cda16a27-f029-40a6-a0e8-2bed0de71169 | 2025-08-19 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Preferred Pharmaceuticals, Inc. | 4ee466dc-5a4e-4c77-8e94-8b510cafd61b | 2025-08-19 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | REMEDYREPACK INC. | 832fc274-605a-4b04-b327-dbf361131621 | 2025-07-24 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 325acf27-4b2e-40e8-8344-bb6cc9959910 | 2025-03-27 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | NuCare Pharmaceuticals,Inc. | d5df10bc-16ed-7a97-e053-2a95a90ab15e | 2024-12-24 | Warnings, Adverse reactions | 210614 ANDA210614 |
| Nifedipine | NIFEDIPINE | NCS HealthCare of KY, LLC dba Vangard Labs | 0cabe053-3b7e-4dcb-8441-ef7821bb6f68 | 2024-10-18 | Warnings, Adverse reactions | 210614 ANDA210614 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-7080-06 | 00904708006 | 50 BLISTER PACK in 1 CARTON (0904-7080-06) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 50 blister pack | 2019-03-12 | 2022-09-30 | No | No | Current |