Glycopyrrolate
Glycopyrrolate Injection, USP(For Intravenous or Intramuscular Use)
Approved
Approval ID
a9164597-f5dc-4fbf-b789-9bed9ffbae79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2022
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycopyrrolate
PRODUCT DETAILS
NDC Product Code16714-906
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 8, 2022
Generic NameGlycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Glycopyrrolate
PRODUCT DETAILS
NDC Product Code16714-998
Application NumberANDA211705
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 8, 2022
Generic NameGlycopyrrolate
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT