Nifedipine

Product NDC: 50090-5328
Requested package NDC: 50090-5328-2
11-digit product format: 500905328
Labeler code: 50090
Product ID: 50090-5328_6ccf2e72-eb18-47e2-8d27-f7fe64895778
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA203126
Marketing category: ANDA
Marketing start: 2014-11-01
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5328	50090-5328-2	D	Discontinued by firm		2026-08-17

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203126-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03
A203126-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03
A203126-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203126-001	AB2
A203126-002	AB2
A203126-003	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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203126-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203126-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203126-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203126-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203126-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203126-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-001	AB2	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5328-0	2023-02-07	NIFEdipine Extended-release Tablets, USP
50090-5328-1	2023-02-07	NIFEdipine Extended-release Tablets, USP
50090-5328-2	2023-02-07	NIFEdipine Extended-release Tablets, USP
50090-5328-0	2023-01-30	NIFEdipine Extended-release Tablets, USP
50090-5328-1	2023-01-30	NIFEdipine Extended-release Tablets, USP
50090-5328-2	2023-01-30	NIFEdipine Extended-release Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5328-2	EA - Each	50090-5328	fbe7b625-2219-4230-a11a-c3bc3ddb9dcf	1	2022-02-07

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	b885b6b5-71c6-4799-8b23-5ee8c17938a0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	160271a8-7922-2107-e054-00144ff88e88	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	3bf4282f-b063-4d35-8ef0-6f48b98e9deb	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da565525-c77a-0571-e053-2995a90aaa11	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	e3b04484-f330-9523-e053-2995a90a0e45	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	a84be46e-bb0c-d59f-e053-2a95a90aabde	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	5927fcff-9d1a-8322-e053-2991aa0ad289	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	6a68f67f-5b68-4f83-aad8-fc3177f5a0a4	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	4c4f8a8e-3995-4d2e-85d4-b6a45f5fac3e	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Proficient Rx LP	d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Proficient Rx LP	838d6e8f-37b0-48d3-b701-c4fa32a87b85	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	09a04e5f-d3b0-4ee3-b12d-f74203262179	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9ZF7L6G2L	NIFEDIPINE	21829-25-4	NIFEDIPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5328-2	50090532802	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5328-2)	2020-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-release Tablets, USP	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	8