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
NDC Product Code63304-210
Application NumberANDA040844
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2013
Generic NameGlycopyrrolate
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
NDC Product Code63304-211
Application NumberANDA040844
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2013
Generic NameGlycopyrrolate
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