Glycopyrrolate

Product NDC: 0641-6034
11-digit product format: 006416034
Labeler code: 0641
Product ID: 0641-6034_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: West-ward Pharmaceutical Corp.
Application: NDA017558
Marketing category: NDA
Marketing start: 1975-02-06
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 0 mg/mL
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
0641-6034-25	2019-11-13	C162847	48780-1	97449f38-ba6e-f6ea-e053-dbdaa90aa703	61767a0d-c94c-44d8-b35c-316a5731a275

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6034-01	ML - Milliliter	0641-6034	89f1ef4c-9d47-458e-90c4-6c0941b02494	1	2013-02-13
0641-6034-25	ML - Milliliter	0641-6034	c4d775a9-fbc6-4694-b7dd-187ee284e87d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
GLYCOPYRROLATE	ACTIVE INGREDIENT	V92SO9WP2I	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
GLYCOPYRROLATE	ACTIVE MOIETY	V92SO9WP2I	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6034	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	3	Legacy NDC	20120612_61767a0d-c94c-44d8-b35c-316a5731a275.zip