GLYCOPYRROLATE
GLYCOPYRROLATE TABLETS USP 1 mg and 2 mg Rx only
Approved
Approval ID
c4454434-1c7d-333d-e053-2a95a90ab641
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Stason Pharmaceuticals
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 Code60763-482
Product Classification
G
Generic Name
GLYCOPYRROLATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED 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 Code60763-481
Product Classification
G
Generic Name
GLYCOPYRROLATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT