FDA.reportPublic FDA data

DOXORUBICIN HYDROCHLORIDE

Product NDC
68001-629
11-digit product format
680010629
Labeler code
68001
Product ID
68001-629_28d93c64-a421-37e6-e063-6294a90ab77d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXORUBICIN HYDROCHLORIDE
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA215178
Marketing category
ANDA
Marketing start
2025-01-07
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
Rxcui1790115, 1790127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee64805-1a32-49b4-a119-9376fc9e6633Product name520250305
750deab0-bb49-36cc-d493-bfaec857a32eProduct name520190807
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-629-26DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL11
68001-629-26DOXORUBICIN HYDROCHLORIDE25 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL251
68001-629-36DOXORUBICIN HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, LIPOSOMAL101
68001-629-36DOXORUBICIN HYDROCHLORIDE1 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-629-26ML - Milliliter68001-629d3830f22-b352-429f-8390-0351e7d207cb12025-01-14
68001-629-36ML - Milliliter68001-6291fea3672-13ec-4180-9507-77b1ef6331fb12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-629DOXORUBICIN HYDROCHLORIDE INJECTION, SUSPENSION, LIPOSOMAL [BLUEPOINT LABORATORIES]1Current NDC, 4 package rows20250108_b8b66e93-0813-4876-b291-8d7c36a99807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790115DOXOrubicin HCl liposome 20 MG in 10 ML InjectionPSNb8b66e93-0813-4876-b291-8d7c36a998071
1790127DOXOrubicin HCl liposome 50 MG in 25 ML InjectionPSNb8b66e93-0813-4876-b291-8d7c36a998071
179011510 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDb8b66e93-0813-4876-b291-8d7c36a998071
179012725 ML doxorubicin hydrochloride liposome 2 MG/ML InjectionSCDb8b66e93-0813-4876-b291-8d7c36a998071
1790115doxorubicin hydrochloride liposome 20 MG per 10 ML InjectionSYb8b66e93-0813-4876-b291-8d7c36a998071
1790127doxorubicin hydrochloride liposome 50 MG per 25 ML InjectionSYb8b66e93-0813-4876-b291-8d7c36a998071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-629-26680010629261 VIAL, SINGLE-USE in 1 CARTON (68001-629-26) / 25 mL in 1 VIAL, SINGLE-USE2025-01-07NoNoCurrent
68001-629-36680010629361 VIAL, SINGLE-USE in 1 CARTON (68001-629-36) / 10 mL in 1 VIAL, SINGLE-USE2025-01-07NoNoCurrent