METHSCOPOLAMINE BROMIDE
Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg Bayshore Pharmaceuticals LLC
Approved
Approval ID
5c74bfb0-c80a-4a86-acd1-1e3a1b20255d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2020
Manufacturers
FDA
BAYSHORE PHARMACEUTICALS LLC
DUNS: 968737416
Products 2
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 Code76385-100
Application NumberANDA200602
Product Classification
M
Marketing Category
C73584
G
Generic Name
methscopolamine bromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2019
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHSCOPOLAMINE BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
methscopolamine bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-101
Application NumberANDA200602
Product Classification
M
Marketing Category
C73584
G
Generic Name
methscopolamine bromide
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2019
FDA Product Classification
INGREDIENTS (5)
METHSCOPOLAMINE BROMIDEActive
Quantity: 5 mg in 1 1
Code: RTN51LK7WL
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT