Glycopyrrolate
Glycopyrrolate Tablets USP
Approved
Approval ID
c18b8ba5-ffee-4575-86d7-ad45268da733
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2016
Manufacturers
FDA
Par Formulations Private Limited
DUNS: 676159161
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 Code43227-065
Application NumberANDA040653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2016
FDA Product Classification
INGREDIENTS (6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43227-066
Application NumberANDA040653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2016
FDA Product Classification
INGREDIENTS (6)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 2 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT