Glycopyrrolate
Glycopyrrolate 1 mg 2 mg
Approved
Approval ID
6cb78e77-3c69-4cda-8a99-7e818c9337c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2018
Manufacturers
FDA
Stason Pharmaceuticals, Inc.
DUNS: 807437553
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 Code60763-476
Application NumberANDA091182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2018
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 2 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60763-475
Application NumberANDA091182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2018
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT