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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

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Glycopyrrolate - FDA Drug Approval Details