Nitroglycerin

Product NDC: 62175-123
11-digit product format: 621750123
Labeler code: 62175
Product ID: 62175-123_6a6fb426-9ed2-4741-921b-2b8102b6ab29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: FILM, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Kremers Urban Pharmaceuticals Inc.
Application: ANDA075115
Marketing category: ANDA
Marketing start: 2004-08-10
Marketing end: 0000-00-00
Substance: NITROGLYCERIN
Active strength: 21 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62175-123-01	2019-10-29	C162847	48780-1	960f7f55-bf6c-8e05-e053-dbdaa90a074a	a1648bd9-8a89-4292-b703-aa83d9bd6c6d
62175-123-11	2019-10-29	C162847	48780-1	960f7f55-bf6c-8e05-e053-dbdaa90a074a	a1648bd9-8a89-4292-b703-aa83d9bd6c6d
62175-123-31	2019-10-29	C162847	48780-1	960f7f55-bf6c-8e05-e053-dbdaa90a074a	a1648bd9-8a89-4292-b703-aa83d9bd6c6d

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62175-123-01	EA - Each	62175-123	1c071fcf-11c9-4239-b179-084ac08f8539	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	NITROGLYCERIN FILM, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	3
Nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	NITROGLYCERIN FILM, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62175-123	NITROGLYCERIN FILM, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	3	Legacy NDC	20110830_a1648bd9-8a89-4292-b703-aa83d9bd6c6d.zip