Bethanechol Chloride
Product Information Bethanechol Chloride Tablets, USP
Approved
Approval ID
6a0a2d15-e67c-41d9-85fd-bafe9b3fb7e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2012
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-968
Application NumberANDA040518
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2012
FDA Product Classification
INGREDIENTS (8)
BETHANECHOL CHLORIDEActive
Quantity: 50 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT