FDA.reportPublic FDA data

Propafenone HCl

Product NDC
0591-0582
11-digit product format
005910582
Labeler code
0591
Product ID
0591-0582_2e5ad1da-4d1b-4ebc-a9af-6d4d7d1cc97d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propafenone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA075203
Marketing category
ANDA
Marketing start
2000-10-24
Marketing end
2026-06-30
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propafenone HCl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPAFENONE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33XCH0HOCD
Rxcui861424, 861427

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
0591-0582-01Propafenone HCl100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0582-01EA - Each0591-0582b181d9cb-553a-41b0-a451-b585b01628a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPAFENONE HYDROCHLORIDEACTIVE INGREDIENT33XCH0HOCDPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
PROPAFENONEACTIVE MOIETY68IQX3T69UPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17
TRIACETININACTIVE INGREDIENTXHX3C3X673PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0582PROPAFENONE HCL (PROPAFENONE HYDROCHLORIDE) TABLET, FILM COATED [ACTAVIS PHARMA, INC.]23Current NDC, Legacy NDC, 1 package rows20190326_a313c111-e539-47bc-9d57-c3767f74bcca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861424propafenone HCl 150 MG Oral TabletPSNa313c111-e539-47bc-9d57-c3767f74bcca24
861427propafenone HCl 225 MG Oral TabletPSNa313c111-e539-47bc-9d57-c3767f74bcca24
861424propafenone hydrochloride 150 MG Oral TabletSCDa313c111-e539-47bc-9d57-c3767f74bcca24
861427propafenone hydrochloride 225 MG Oral TabletSCDa313c111-e539-47bc-9d57-c3767f74bcca24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0582-0100591058201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0582-01) 2000-10-242026-06-30NoNoCurrent