GLYCOPYRROLATE 1ML
Glycopyrrolate Injection
Approved
Approval ID
1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
XIROMED LLC
DUNS: 080228637
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 Code70700-264
Application NumberANDA212227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT