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Bethanechol Chloride

Bethanechol Chloride Tablets, USPRx only

Approved
Approval ID

78c09ab4-35fc-4cad-a133-d7ad8ae1fec3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 29, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-2023
Application NumberANDA040728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2020
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Bethanechol Chloride - FDA Drug Approval Details