GLYRX-PF
These highlights do not include all the information needed to use GLYRX-PF safely and effectively. See full prescribing information for GLYRX-PF.GLYRX-PF (glycopyrrolate injection), for intravenous or intramuscular useInitial U.S. Approval: 1975
Approved
Approval ID
2189f3f5-39dc-4e85-b7c6-9515ded59686
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2018
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
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 Code51754-6013
Application NumberNDA210997
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 1, 2018
Generic Nameglycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
glycopyrrolate
PRODUCT DETAILS
NDC Product Code51754-6000
Application NumberNDA210997
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 1, 2018
Generic Nameglycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
glycopyrrolate
PRODUCT DETAILS
NDC Product Code51754-6001
Application NumberNDA210997
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 1, 2018
Generic Nameglycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
glycopyrrolate
PRODUCT DETAILS
NDC Product Code51754-6015
Application NumberNDA210997
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateAugust 1, 2018
Generic Nameglycopyrrolate
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB