Glycopyrrolate
GLYCOPYRROLATE INJECTION, USPRx onlyNOT FOR USE IN NEONATESCONTAINS BENZYL ALCOHOL
Approved
Approval ID
e620e03e-aab9-436f-93cb-9f717f25b89f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 4
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 Code70748-139
Application NumberANDA213655
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 4 mg in 20 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70748-137
Application NumberANDA213655
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.4 mg in 2 mL
Code: V92SO9WP2I
Classification: ACTIB
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70748-138
Application NumberANDA213655
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70748-136
Application NumberANDA213655
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT