METHSCOPOLAMINE BROMIDE
Methscopolamine Bromide Tablets, USP 2.5 mg
Approved
Approval ID
26cd56db-4727-40d1-8f08-3ee899052c77
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methscopolamine bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43063-740
Application NumberANDA200602
Product Classification
M
Marketing Category
C73584
G
Generic Name
methscopolamine bromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHSCOPOLAMINE BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/24/2019
Rx Only