GLYCOPYRROLATE
Glycopyrrolate Injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL
Approved
Approval ID
7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2021
Manufacturers
FDA
Nivagen Pharmaceuticals, Inc.
DUNS: 052032418
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 Code75834-195
Application NumberANDA212591
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 29, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code75834-193
Application NumberANDA212591
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 29, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code75834-194
Application NumberANDA212591
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 29, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code75834-196
Application NumberANDA212591
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 29, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT