Nifedipine

Product NDC
68788-0167
11-digit product format
687880167
Labeler code
68788
Product ID
68788-0167_49dd956b-f628-4527-ad36-426e06daa0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077127
Marketing category
ANDA
Marketing start
2015-04-23
Marketing end
0000-00-00
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
2019-12-31
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.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-0167DDiscontinued by firm2026-08-03
excluded packagepackage68788-016768788-0167-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-016768788-0167-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-016768788-0167-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-016768788-0167-9DDiscontinued by firm2026-08-03

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.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-0167-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-0167-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-0167-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-0167-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-0167-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-0167-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-0167-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-0167-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-0167-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-0167-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-0167-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-0167-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-0167-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-0167-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-0167-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-0167-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-0167-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-0167-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-0167-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-0167-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-0167-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-0167-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-0167-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-0167-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-0167-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-0167-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-0167-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-0167-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-0167-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-0167-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-0167-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-0167-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-0167-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-0167-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-0167-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-0167-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-0167-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-0167-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-0167-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-0167-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-0167-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-0167-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-0167-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-0167-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-0167-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-0167-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-0167-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-0167-6557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077127-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21
A077127-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21
A077127-003NIFEDIPINENIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077127-001AB2
A077127-002AB2
A077127-003AB2

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22005-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALAB22007-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077127-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22005-11-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077127-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077127-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077127-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077127-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077127-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077127-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077127-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077127-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077127-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077127-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077127-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077127-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A077127-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077127-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077127-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077127-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077127-001AB218072bd15b7f6…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2

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.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nifedipine ERNIFEDIPINEAvPAKd1a78ff2-7672-3e69-00ef-63d203c804842026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEChartwell RX, LLC0a8e3090-7733-4914-bacb-01bbdc8deb302025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEPD-Rx Pharmaceuticals, Inc.86c1bdae-c749-4ec3-90f6-7ebe8e76c4612025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINECardinal Health 107, LLC593d8ca3-c303-4512-96a6-d4860e02cd832025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEAmerican Health Packagingb11026f8-dea0-49ac-8725-0ef7dc27923f2025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEPD-Rx Pharmaceuticals, Inc.75003769-7800-4bc7-b709-35b4caec2c2f2025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINELannett Company, Inc.331db003-cc8e-4509-9415-20e48c5cc5b22023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEA-S Medication Solutionsec13ec71-626f-4664-b264-f67ba72071ae2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127
NifedipineNIFEDIPINEProficient Rx LP4b6418a8-600f-470e-adf1-56207bb25c382019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077127
application number: ANDA077127