doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form INJECTION, SUSPENSION, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-339
Product ID 70748-339_e9f76142-15d0-4234-8f2e-5f5014160eff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215178
Listing Expiration 2026-12-31
Marketing Start 2024-08-26

Pharmacologic Class

Classes
anthracycline topoisomerase inhibitor [epc] anthracyclines [cs] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748339
Hyphenated Format 70748-339

Supplemental Identifiers

RxCUI
1790115 1790127
UNII
82F2G7BL4E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name doxorubicin hydrochloride (source: ndc)
Generic Name doxorubicin hydrochloride (source: ndc)
Application Number ANDA215178 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

70748-339-01 1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

doxorubicin hydrochloride (2 mg/mL)

Linked Drug Pages (1)

DOXORUBICIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e9f76142-15d0-4234-8f2e-5f5014160eff", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["0f8eb9a1-74d0-47fd-94b8-a65b29006521"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "70748-339-01", "marketing_start_date": "20240826"}], "brand_name": "DOXORUBICIN HYDROCHLORIDE", "product_id": "70748-339_e9f76142-15d0-4234-8f2e-5f5014160eff", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "70748-339", "generic_name": "DOXORUBICIN HYDROCHLORIDE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXORUBICIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA215178", "marketing_category": "ANDA", "marketing_start_date": "20240826", "listing_expiration_date": "20261231"}