FDA.reportPublic FDA data

doxorubicin hydrochloride

Product NDC
25021-207
11-digit product format
250210207
Labeler code
25021
Product ID
25021-207_f327fef8-8ebd-45a2-a339-72e702c4f8b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxorubicin hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA209825
Marketing category
ANDA
Marketing start
2013-10-31
Substance
DOXORUBICIN HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
doxorubicin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXORUBICIN HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82F2G7BL4E
Rxcui1191138, 1790100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-207-25doxorubicin hydrochloride1 in 1 CARTONINJECTION, SOLUTION114
25021-207-25doxorubicin hydrochloride25 mL in 1 VIALINJECTION, SOLUTION2514
25021-207-51doxorubicin hydrochloride1 in 1 CARTONINJECTION, SOLUTION114
25021-207-51doxorubicin hydrochloride100 mL in 1 VIALINJECTION, SOLUTION10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-207-05ML - Milliliter25021-2079201bce7-9485-4fee-9933-8a26bd08a34812013-11-04
25021-207-25ML - Milliliter25021-207a3d998cc-a1e6-4544-990a-e65c6e41db7412013-11-04
25021-207-51ML - Milliliter25021-2074074ed26-9bd3-4988-bb11-d2243766fef712013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
doxorubicin hydrochlorideACTIVE INGREDIENT82F2G7BL4EDOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10
doxorubicinACTIVE MOIETY80168379AGDOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10
waterINACTIVE INGREDIENT059QF0KO0RDOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-207DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]13Current NDC, Legacy NDC, 4 package rows20230809_ae80bd3a-b99a-4e01-a444-b9d05687f00e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191138DOXOrubicin HCl 2 MG/ML Injectable SolutionPSNae80bd3a-b99a-4e01-a444-b9d05687f00e14
1790100DOXOrubicin HCl 50 MG in 25 ML InjectionPSNae80bd3a-b99a-4e01-a444-b9d05687f00e14
179010025 ML doxorubicin hydrochloride 2 MG/ML InjectionSCDae80bd3a-b99a-4e01-a444-b9d05687f00e14
1191138doxorubicin hydrochloride 2 MG/ML Injectable SolutionSCDae80bd3a-b99a-4e01-a444-b9d05687f00e14
1790100doxorubicin hydrochloride 50 MG per 25 ML InjectionSYae80bd3a-b99a-4e01-a444-b9d05687f00e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-207-25250210207251 VIAL in 1 CARTON (25021-207-25) / 25 mL in 1 VIAL1 vial2013-10-31NoNoCurrent
25021-207-51250210207511 VIAL in 1 CARTON (25021-207-51) / 100 mL in 1 VIAL1 vial2013-10-31NoNoCurrent