Nifedipine

Product NDC: 50090-3034
Requested package NDC: 50090-3034-2
11-digit product format: 500903034
Labeler code: 50090
Product ID: 50090-3034_5b46d2e6-5d7f-4aa8-9a69-d69002bc4f2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077899
Marketing category: ANDA
Marketing start: 2016-03-02
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: 2020-12-31
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	50090-3034	50090-3034-2	I	Inactivated by FDA		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.

Historic NDC status page 1 of 1 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077899-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13
A077899-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13
A077899-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077899-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077899-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2012-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077899-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2006-12-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077899-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077899-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077899-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077899-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077899-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077899-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077899-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077899-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077899-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077899-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077899-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077899-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077899-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077899-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077899-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077899-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077899-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077899-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077899-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077899-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077899-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077899-003	AB1	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3034-0	2023-01-30	C162847	48780-1	f386c64a-1664-0266-e053-dadaa90a7c1a	NIFEdipine Extended-Release Tablet, USP
50090-3034-1	2023-01-30	C162847	48780-1	f386c64a-1664-0266-e053-dadaa90a7c1a	NIFEdipine Extended-Release Tablet, USP
50090-3034-2	2023-01-30	C162847	48780-1	f386c64a-1664-0266-e053-dadaa90a7c1a	NIFEdipine Extended-Release Tablet, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3034-0	Nifedipine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	6
50090-3034-1	Nifedipine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100	6
50090-3034-2	Nifedipine	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3034-0	EA - Each	50090-3034	80d2277c-5e25-4e58-8942-cc301677ac3f	1	2018-11-06
50090-3034-1	EA - Each	50090-3034	bba73239-29d3-426f-abad-6cb63ee15fc4	1	2019-05-02
50090-3034-2	EA - Each	50090-3034	75f272f9-4439-4135-92c3-b0990d145338	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3034	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	6	Legacy NDC, 3 package rows	20190427_16e58a0a-b79b-46b9-ac14-9b1a0578eeab.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198034	NIFEdipine 30 MG 24HR Extended Release Oral Tablet	PSN	16e58a0a-b79b-46b9-ac14-9b1a0578eeab	6
198034	24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	16e58a0a-b79b-46b9-ac14-9b1a0578eeab	6
198034	nifedipine 30 MG 24 HR Extended Release Oral Tablet	SY	16e58a0a-b79b-46b9-ac14-9b1a0578eeab	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3034-2	50090303402	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3034-2)	2016-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-Release Tablet, USP	A-S Medication Solutions	2019-04-26	HUMAN PRESCRIPTION DRUG LABEL	6