GLYCOPYRROLATE
Glycopyrrolate Injection, USP
Approved
Approval ID
d82ca14f-2116-4ec1-b497-1c9d6db4d5e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0765
Application NumberNDA017558
Product Classification
M
Marketing Category
C73594
G
Generic Name
glycopyrrolate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Quantity: 9.0 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT