FDA.reportPublic FDA data

Daunorubicin Hydrochloride

Product NDC
42658-021
11-digit product format
426580021
Labeler code
42658
Product ID
42658-021_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
42658-021-01Daunorubicin Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION413
42658-021-01Daunorubicin Hydrochloride1 in 1 BOXINJECTION, SOLUTION113
42658-021-02Daunorubicin Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION413
42658-021-02Daunorubicin Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1013
42658-021-91Daunorubicin Hydrochloride1 in 1 BOXINJECTION, SOLUTION14
42658-021-91Daunorubicin Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION44
42658-021-92Daunorubicin Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104
42658-021-92Daunorubicin Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42658-021-01ML - Milliliter42658-0213f827da8-a875-4295-8ebc-99385eca343412020-02-13
42658-021-02ML - Milliliter42658-02122003730-2501-4067-9266-0863c886523312021-04-08
42658-021-91ML - Milliliter42658-021148f1496-ec51-483d-a6b9-de81244d4df912023-03-13
42658-021-92ML - Milliliter42658-021d4537d93-7bd0-45d3-9f69-3eeba279c9a012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42658-021DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 4 package rows20241227_9705fa12-499e-41a3-8fb4-f6df0858b851.zip
42658-021DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 4 package rows20230209_f4312095-3c21-296b-e053-2995a90a0d9c.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
309650DAUNOrubicin HCl 20 MG in 4 ML InjectionPSNf4312095-3c21-296b-e053-2995a90a0d9c4
3096504 ML daunorubicin 5 MG/ML InjectionSCDf4312095-3c21-296b-e053-2995a90a0d9c4
309650daunorubicin (as daunorubicin hydrochloride 5.34 MG) 20 MG per 4 ML InjectionSYf4312095-3c21-296b-e053-2995a90a0d9c4
309650daunorubicin 20 MG per 4 ML InjectionSYf4312095-3c21-296b-e053-2995a90a0d9c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42658-021-01426580021011 VIAL in 1 BOX (42658-021-01) / 4 mL in 1 VIAL1 vial2020-01-200000-00-00NoNoCurrent
42658-021-024265800210210 VIAL in 1 CARTON (42658-021-02) / 4 mL in 1 VIAL10 vial2021-01-270000-00-00NoNoCurrent
42658-021-91426580021911 VIAL in 1 BOX (42658-021-91) / 4 mL in 1 VIAL1 vial2023-01-15NoNoCurrent
42658-021-924265800219210 VIAL in 1 CARTON (42658-021-92) / 4 mL in 1 VIAL10 vial2022-12-190000-00-00NoNoCurrent