Glycopyrrolate
GLYCOPYRROLATE TABLETS, USPRx only
Approved
Approval ID
4ec4e4e4-ce23-463b-9296-bff35b005632
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2013
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
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 Code63304-210
Application NumberANDA040844
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2013
FDA Product Classification
INGREDIENTS (6)
GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-211
Application NumberANDA040844
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2013
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 2 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT