GLYCOPYRROLATE
Glycopyrrolate Tablets, USP 1.5 mg
Approved
Approval ID
18ca98ed-522d-470f-bb22-908bbd7d489a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
FH2 Pharma LLC
DUNS: 116969558
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 Code72887-160
Application NumberANDA091522
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLYCOPYRROLATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (6)
GLYCOPYRROLATEActive
Quantity: 1.5 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM PYROPHOSPHATEInactive
Code: X69NU20D19
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT