glycopyrrolate
NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL
Approved
Approval ID
d9df3900-a8c2-438b-8971-ba11ff91f90b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2022
Manufacturers
FDA
BE Pharmaceuticals Inc.
DUNS: 081499296
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 Code71839-126
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 21, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 4 mg in 20 mL
Code: V92SO9WP2I
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code71839-123
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 21, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
glycopyrrolate
PRODUCT DETAILS
NDC Product Code71839-125
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 21, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code71839-124
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 21, 2021
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.4 mg in 2 mL
Code: V92SO9WP2I
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT