nifedipine

Product NDC: 59762-6692
11-digit product format: 597626692
Labeler code: 59762
Product ID: 59762-6692_d6a5443f-c368-4b51-917f-fba3fc92ef58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Greenstone LLC
Application: NDA019684
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-03-31
Marketing end: 0000-00-00
Substance: NIFEDIPINE
Active strength: 90 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-6692-3	EA - Each	59762-6692	b2d457a0-9b47-4b9d-a527-57bf269f02b1	1	2012-07-24
59762-6692-8	EA - Each	59762-6692	d79a0e7c-71b7-4420-ae8f-1353fcce17f3	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nifedipine	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
nifedipine	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

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
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	60b85eab-17ad-4482-87d6-ca9720ca06e0	2
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	60b85eab-17ad-4482-87d6-ca9720ca06e0	2
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	60b85eab-17ad-4482-87d6-ca9720ca06e0	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEDIPINE Extended Release Tablets 30 mg, 60 mg, and 90 mg	Physicians Total Care, Inc.	2012-02-01	HUMAN PRESCRIPTION DRUG LABEL	2