MedPath
FDA Approval

Disopyramide Phosphate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 28, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Disopyramide(100 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Disopyramide Phosphate

Product Details

NDC Product Code
0093-3127
Application Number
ANDA070101
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2022
Code: N6BOM1935WClass: ACTIMQuantity: 100 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

Disopyramide Phosphate

Product Details

NDC Product Code
0093-3129
Application Number
ANDA070102
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2022
Code: N6BOM1935WClass: ACTIMQuantity: 150 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
© Copyright 2025. All Rights Reserved by MedPath