Bethanechol Chloride
Bethanechol Chloride Tablets, USPRx only
Approved
Approval ID
45285692-de51-413e-8a51-7fb792eccc81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 4
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 Code65162-571
Application NumberANDA040855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (6)
BETHANECHOL CHLORIDEActive
Quantity: 5 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-572
Application NumberANDA040855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 10 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-574
Application NumberANDA040855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 50 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-573
Application NumberANDA040855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (8)
BETHANECHOL CHLORIDEActive
Quantity: 25 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT