Bethanechol Chloride
Bethanechol Chloride
Approved
Approval ID
8d49c7d7-a1ae-423d-98d5-a2fcd5fa3bc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2015
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 3
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 Code10135-518
Application NumberANDA040677
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2015
FDA Product Classification
INGREDIENTS (8)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 50 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-517
Application NumberANDA040678
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2015
FDA Product Classification
INGREDIENTS (6)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 25 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-516
Application NumberANDA040704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2015
FDA Product Classification
INGREDIENTS (6)
BETHANECHOL CHLORIDEActive
Quantity: 10 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 5/28/2015
Bethanechol** Chloride**
**Tablets,**USP
Rx only