Bethanechol Chloride
Bethanechol Chloride Tablets, USP Rx only
Approved
Approval ID
cb6a43e9-5663-47e1-8f77-ed4cb806436d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2020
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
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 Code0527-1332
Application NumberANDA040677
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2020
FDA Product Classification
INGREDIENTS (6)
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 CHLORIDEActive
Quantity: 5 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1340
Application NumberANDA040677
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
BETHANECHOL CHLORIDEActive
Quantity: 10 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
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 Code0527-1329
Application NumberANDA040677
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2020
FDA Product Classification
INGREDIENTS (8)
BETHANECHOL CHLORIDEActive
Quantity: 50 mg in 1 1
Code: H4QBZ2LO84
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Bethanechol Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1356
Application NumberANDA040677
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bethanechol Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2020
FDA Product Classification
INGREDIENTS (6)
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
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT