Glycopyrrolate
Glycopyrrolate Injection, USP(For Intravenous or Intramuscular Use)
Approved
Approval ID
3535bfc0-67c8-469b-aea7-95cee4681fa8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2022
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-408
Application NumberANDA211705
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (5)
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-407
Application NumberANDA211705
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (5)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT