Nifedipine

Product NDC: 0378-0481
11-digit product format: 003780481
Labeler code: 0378
Product ID: 0378-0481_b154bdb7-f761-491f-9a9c-14d23e9a1b52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090649
Marketing category: ANDA
Marketing start: 2000-03-14
Marketing end: 2019-11-30
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: 0000-00-00
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	0378-0481		D	Discontinued by firm	2026-08-03
excluded package	package	0378-0481	0378-0481-01	D	Discontinued by firm	2026-08-03
excluded package	package	0378-0481	0378-0481-30	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 · 36 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	0378-0481-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0481-30	`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	0378-0481-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0481-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0481-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0481-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0481-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0481-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0481-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0481-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0481-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0481-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0481-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0481-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0481-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0481-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0481-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0481-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0481-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0481-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0481-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0481-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0481-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0481-30	`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
A090649-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21
A090649-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21
A090649-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21

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	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090649-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090649-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2010-06-21	`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	A090649-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090649-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090649-003	AB2	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090649-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090649-002	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090649-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090649-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090649-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090649-003	AB2	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0481-01	EA - Each	0378-0481	e8758ae2-607e-47df-ab24-aa41fd3f6523	1	2012-07-24
0378-0481-30	EA - Each	0378-0481	87ba8927-4bcf-4a78-b844-deb1ab6e1b70	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.]	7
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	2
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]	1

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
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	445fbfa9-ef9a-42d3-a7d5-5a48f8b0af21	1
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	445fbfa9-ef9a-42d3-a7d5-5a48f8b0af21	1
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	445fbfa9-ef9a-42d3-a7d5-5a48f8b0af21	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2017-12-08	HUMAN PRESCRIPTION DRUG LABEL	4
Nifedipine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2017-06-29	HUMAN PRESCRIPTION DRUG LABEL	12
Nifedipine ER Tabs	NCS HealthCare of KY, Inc dba Vangard Labs	2013-02-25	HUMAN PRESCRIPTION DRUG LABEL	6
NIFEDIPINE - STAT RX USA LLC	STAT RX USA LLC	2011-08-04	HUMAN PRESCRIPTION DRUG LABEL	1