Glycopyrrolate
GLYCOPYRROLATE TABLETS, USP, 1.5 MG
Approved
Approval ID
06bb6f89-4694-4aaa-8bff-f7f3c81d3add
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2019
Manufacturers
FDA
Nexgen Pharma, Inc.
DUNS: 048488621
Products 1
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 Code0722-7097
Application NumberANDA091522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2019
FDA Product Classification
INGREDIENTS (6)
GLYCOPYRROLATEActive
Quantity: 1.5 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PYROPHOSPHATEInactive
Code: X69NU20D19
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT