Glycopyrrolate
These highlights do not include all the information needed to use glycopyrrolate safely and effectively. See full prescribing information for glycopyrrolate. Glycopyrrolate oral solution Initial U.S. Approval: 1961
Approved
Approval ID
2b6ae63e-3d3c-4f72-9ceb-6e5f7c6c53b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2022
Manufacturers
FDA
Merz Pharmaceuticals, LLC
DUNS: 126209282
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 Code0259-0502
Application NumberNDA022571
Product Classification
M
Marketing Category
C73605
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (10)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT