FDA.reportPublic FDA data

Propafenone Hydrochloride

Product NDC
62559-231
11-digit product format
625590231
Labeler code
62559
Product ID
62559-231_f3d9c704-c65d-43cd-aafd-2aebe4abfee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA076550
Marketing category
ANDA
Marketing start
2015-03-31
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861424, 861427, 861430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
559c7edd-6d87-934f-8fcc-0cd5e9651949Product name720240226
06783798-d93a-d4be-8416-24bb30819d48Product name220160630

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-231-01Propafenone Hydrochloride100 in 1 BOTTLETABLET, COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-231-01EA - Each62559-231101b40ae-d1c9-46c1-bc31-1cd555e1fb0012015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPAFENONE HYDROCHLORIDEACTIVE INGREDIENT33XCH0HOCDPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
PROPAFENONEACTIVE MOIETY68IQX3T69UPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673PROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-231PROPAFENONE HYDROCHLORIDE TABLET, COATED [ANI PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20181130_8d1be333-be2b-4064-86a4-c2ad9ad07b83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861427propafenone HCl 225 MG Oral TabletPSN2492317c-8b04-477e-a5d2-53e791fface9104
861427propafenone hydrochloride 225 MG Oral TabletSCD2492317c-8b04-477e-a5d2-53e791fface9104
861427propafenone HCl 225 MG Oral TabletPSN5c8cebcd-699f-4c4c-900b-94e0fe519345101
861427propafenone hydrochloride 225 MG Oral TabletSCD5c8cebcd-699f-4c4c-900b-94e0fe519345101
861424propafenone HCl 150 MG Oral TabletPSN7202aed6-40a9-2bff-e053-2a95a90ae7529
861427propafenone HCl 225 MG Oral TabletPSN7202aed6-40a9-2bff-e053-2a95a90ae7529
861430propafenone HCl 300 MG Oral TabletPSN7202aed6-40a9-2bff-e053-2a95a90ae7529
861424propafenone hydrochloride 150 MG Oral TabletSCD7202aed6-40a9-2bff-e053-2a95a90ae7529
861427propafenone hydrochloride 225 MG Oral TabletSCD7202aed6-40a9-2bff-e053-2a95a90ae7529
861430propafenone hydrochloride 300 MG Oral TabletSCD7202aed6-40a9-2bff-e053-2a95a90ae7529
861427propafenone HCl 225 MG Oral TabletPSN41b4e503-60a6-4662-a6f9-46ecf93d930a6
861427propafenone hydrochloride 225 MG Oral TabletSCD41b4e503-60a6-4662-a6f9-46ecf93d930a6
861424propafenone HCl 150 MG Oral TabletPSN8d1be333-be2b-4064-86a4-c2ad9ad07b834
861427propafenone HCl 225 MG Oral TabletPSN8d1be333-be2b-4064-86a4-c2ad9ad07b834
861430propafenone HCl 300 MG Oral TabletPSN8d1be333-be2b-4064-86a4-c2ad9ad07b834
861424propafenone hydrochloride 150 MG Oral TabletSCD8d1be333-be2b-4064-86a4-c2ad9ad07b834
861427propafenone hydrochloride 225 MG Oral TabletSCD8d1be333-be2b-4064-86a4-c2ad9ad07b834
861430propafenone hydrochloride 300 MG Oral TabletSCD8d1be333-be2b-4064-86a4-c2ad9ad07b834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-231-0162559023101100 TABLET, COATED in 1 BOTTLE (62559-231-01) 2015-03-310000-00-00NoNoCurrent