Bethanechol Chloride
Bethanechol Chloride Tablets, USP - 5 mg, 10 mg, 25 mg, and 50 mg
Approved
Approval ID
89267333-ba8b-455b-a8dc-515a888463c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-756
Application NumberANDA040728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 10 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code62135-758
Application NumberANDA040728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code62135-757
Application NumberANDA040728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 25 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-755
Application NumberANDA040728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 5 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT