FDA.reportPublic FDA data

Idamycin PFS

Product NDC
0013-2596
11-digit product format
000132596
Labeler code
0013
Product ID
0013-2596_d504ef4f-8fe8-447e-8fb3-30846fb2e486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
idarubicin hydrochloride
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050734
Marketing category
NDA
Marketing start
1997-02-17
Substance
IDARUBICIN HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Idamycin PFS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IDARUBICIN HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5VV3MDU5IE
Rxcui1791493, 1791495, 1791498, 1791499, 1791500, 1791501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0013-2596-20Idamycin PFS20 mL in 1 VIAL, SINGLE-DOSESOLUTION2027
0013-2596-20Idamycin PFS1 in 1 CARTONSOLUTION127
0013-2596-91Idamycin PFS20 mL in 1 VIAL, SINGLE-DOSESOLUTION2027
0013-2596-91Idamycin PFS1 in 1 CARTONSOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-2596-20ML - Milliliter0013-2596c08cfb05-d9c0-44d4-af18-d5762fc7f16112024-04-05
0013-2596-91ML - Milliliter0013-259618f9b42f-946c-47ab-bf1f-e206924c3d8b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IDARUBICIN HYDROCHLORIDEACTIVE INGREDIENT5VV3MDU5IEIDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
IDARUBICINACTIVE MOIETYZRP63D75JWIDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
WATERINACTIVE INGREDIENT059QF0KO0RIDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PHARMACIA AND UPJOHN COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-2596IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]25Current NDC, Legacy NDC, 4 package rows20240814_0a5a6d93-cc1e-4d7f-8da1-446c134503b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791499Idamycin 10 MG in 10 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791495Idamycin 20 MG in 20 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791501Idamycin 5 MG in 5 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791498IDArubicin HCl 10 MG in 10 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791493IDArubicin HCl 20 MG in 20 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791500IDArubicin HCl 5 MG in 5 ML InjectionPSN0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149910 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin]SBD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149520 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin]SBD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
17915015 ML idarubicin hydrochloride 1 MG/ML Injection [Idamycin]SBD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149810 ML idarubicin hydrochloride 1 MG/ML InjectionSCD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149320 ML idarubicin hydrochloride 1 MG/ML InjectionSCD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
17915005 ML idarubicin hydrochloride 1 MG/ML InjectionSCD0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149910 ML Idamycin 1 MG/ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
179149520 ML Idamycin 1 MG/ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
17915015 ML Idamycin 1 MG/ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791499Idamycin 10 MG per 10 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791495Idamycin 20 MG per 20 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791501Idamycin 5 MG per 5 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791498idarubicin HCl 10 MG per 10 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791493idarubicin HCl 20 MG per 20 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327
1791500idarubicin HCl 5 MG per 5 ML InjectionSY0a5a6d93-cc1e-4d7f-8da1-446c134503b327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-2596-20000132596201 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-20) / 20 mL in 1 VIAL, SINGLE-DOSE2024-03-11NoNoHistorical
0013-2596-91000132596911 VIAL in 1 CARTON (0013-2596-91) > 20 mL in 1 VIAL1 vial1997-02-170000-00-00NoNoCurrent