Nifedipine

Product NDC: 68151-2870
11-digit product format: 681512870
Labeler code: 68151
Product ID: 68151-2870_81bf021b-a6f9-4a01-a725-2b1c441024a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: CAPSULE
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA072781
Marketing category: ANDA
Marketing start: 2009-08-11
Marketing end: 0000-00-00
Substance: NIFEDIPINE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-2870-2	2020-01-31	C162847	48780-1	9d75b9d0-f883-f424-e053-dadaa90a57ce	Nifedipine Capsules

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-2870-2	Nifedipine	1 in 1 PACKAGE	CAPSULE	1		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-2870	NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20140822_ce3366e2-ede3-4321-bd1c-8aacc869fe46.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198032	NIFEdipine 10 MG Oral Capsule	PSN	ce3366e2-ede3-4321-bd1c-8aacc869fe46	2
198032	nifedipine 10 MG Oral Capsule	SCD	ce3366e2-ede3-4321-bd1c-8aacc869fe46	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-2870-2	68151287002	1 in 1 PACKAGE	Historical