Nifedipine

Product NDC: 0378-0360
Requested package NDC: 0378-0360-01
11-digit product format: 003780360
Labeler code: 0378
Product ID: 0378-0360_d5517e8c-6f72-4ee3-967c-e60b00266b9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA201071
Marketing category: ANDA
Marketing start: 2010-12-20
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: 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	0378-0360	0378-0360-01	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.

Historic NDC status page 1 of 1 · 12 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…`

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
A201071-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03
A201071-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03

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	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201071-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201071-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201071-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-12-03	`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	A201071-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201071-003	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201071-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201071-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201071-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201071-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201071-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201071-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201071-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201071-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201071-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201071-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201071-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201071-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201071-003	AB1	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0360-01	EA - Each	0378-0360	a643824c-d050-4071-b3b6-12494fc7352c	1	2012-07-24
0378-0360-10	EA - Each	0378-0360	a55cc1e3-0a2c-41ed-8304-88225952f0ef	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

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
0378-0360-01	00378036001	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0360-01)	2010-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Nifedipine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2018-07-24	HUMAN PRESCRIPTION DRUG LABEL	9