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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

NDC Product Code70748-139
Application NumberANDA213655
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
Generic NameGlycopyrrolate

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

NDC Product Code70748-137
Application NumberANDA213655
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
Generic NameGlycopyrrolate

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

NDC Product Code70748-138
Application NumberANDA213655
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
Generic NameGlycopyrrolate

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

NDC Product Code70748-136
Application NumberANDA213655
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateFebruary 16, 2023
Generic NameGlycopyrrolate

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