Nifedipine

Product NDC: 50090-4234
11-digit product format: 500904234
Labeler code: 50090
Product ID: 50090-4234_ec8c027d-e7c1-460f-a5ff-8443a811bf8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075269
Marketing category: ANDA
Marketing start: 2000-12-04
Marketing end: 0000-00-00
Substance: NIFEDIPINE
Active strength: 60 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-4234		D	Discontinued by firm	2026-08-07
excluded package	package	50090-4234	50090-4234-0	D	Discontinued by firm	2026-08-07
excluded package	package	50090-4234	50090-4234-2	D	Discontinued by firm	2026-08-07

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4234-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4234-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4234-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4234-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075269-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04
A075269-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075269-001	AB1
A075269-002	AB1

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075269-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	AB1	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4234-0	2023-02-07	Nifedipine Extended-Release Tablets, USP 60 mg
50090-4234-2	2023-02-07	Nifedipine Extended-Release Tablets, USP 60 mg
50090-4234-0	2023-01-30	Nifedipine Extended-Release Tablets, USP 60 mg
50090-4234-2	2023-01-30	Nifedipine Extended-Release Tablets, USP 60 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4234-0	EA - Each	50090-4234	62ba92ae-5da3-4b02-8e97-e3f78d97dbf6	1	2023-09-05
50090-4234-2	EA - Each	50090-4234	9ea1dbb3-4e64-4aa3-908f-1585b6495e8f	1	2022-01-06

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	fb6d8f32-198e-4ccf-bf25-069c03d624fd	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	d9dec600-4e11-8292-e053-2a95a90a6842	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	cb051508-60f3-4b89-9da0-5261024bd7f4	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	81e6c8e7-e826-4abb-ad58-1dee62091a66	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	A-S Medication Solutions	af5a6330-1819-4724-9f08-da45ac9fb478	2023-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	95a53fc5-852d-4892-af20-2aaece9399ba	2018-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269

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
50090-4234-0	50090423400	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-0)	2019-03-28	0000-00-00	No	No	Current
50090-4234-2	50090423402	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4234-2)	2019-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP 60 mg	A-S Medication Solutions	2023-08-09	HUMAN PRESCRIPTION DRUG LABEL	8