Glycopyrrolate
Glycopyrrolate Injection, USP
Approved
Approval ID
54458620-d888-4df6-ae4b-78c3dfed3423
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-578
Application NumberANDA209328
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 16, 2023
FDA Product Classification
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT