METHSCOPOLAMINE BROMIDE
Methscopolamine Bromide Tablets, USP 5 mg
Approved
Approval ID
8a14ade6-d428-4144-9037-46955f68820f
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 Code43063-741
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHSCOPOLAMINE BROMIDEActive
Quantity: 5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT