FDA.reportPublic FDA data

Daunorubicin Hydrochloride

Product NDC
42658-019
11-digit product format
426580019
Labeler code
42658
Product ID
42658-019_48b4337a-9cc5-665d-e063-6294a90a1613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daunorubicin hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hisun Pharmaceuticals USA, Inc.
Application
ANDA208759
Marketing category
ANDA
Marketing start
2020-01-20
Substance
DAUNORUBICIN HYDROCHLORIDE
Active strength
5 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
Daunorubicin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAUNORUBICIN HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUD984I04LZ
Rxcui309650, 2002002

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f3d1868e-0da1-260e-6cc5-cbfb549f6366Product name220190716
b26a2c57-24d3-40e9-b4c6-b86b5dc74861Product name120190711
675b5a39-d8c3-40a3-b593-72d314eef224Product name120170829
9592a3dd-cd44-4c6e-e6ce-f07b344af1ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42658-019-01Daunorubicin Hydrochloride1 in 1 BOXINJECTION, SOLUTION113
42658-019-01Daunorubicin Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42658-019-01ML - Milliliter42658-019eef1d5b5-f7f3-4225-93b4-576cfcba579012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42658-019DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 2 package rows20241227_9705fa12-499e-41a3-8fb4-f6df0858b851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002002DAUNOrubicin 50 MG in 10 ML InjectionPSN9705fa12-499e-41a3-8fb4-f6df0858b85113
309650DAUNOrubicin HCl 20 MG in 4 ML InjectionPSN9705fa12-499e-41a3-8fb4-f6df0858b85113
200200210 ML daunorubicin 5 MG/ML InjectionSCD9705fa12-499e-41a3-8fb4-f6df0858b85113
3096504 ML daunorubicin 5 MG/ML InjectionSCD9705fa12-499e-41a3-8fb4-f6df0858b85113
309650daunorubicin (as daunorubicin hydrochloride 5.34 MG) 20 MG per 4 ML InjectionSY9705fa12-499e-41a3-8fb4-f6df0858b85113
2002002daunorubicin (as daunorubicin hydrochloride 5.34 MG) 50 MG per 10 ML InjectionSY9705fa12-499e-41a3-8fb4-f6df0858b85113
309650daunorubicin 20 MG per 4 ML InjectionSY9705fa12-499e-41a3-8fb4-f6df0858b85113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42658-019-01426580019011 VIAL in 1 BOX (42658-019-01) / 10 mL in 1 VIAL1 vial2020-01-200000-00-00NoNoCurrent