doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION, SUSPENSION, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-525
Product ID 46708-525_f8e001f5-441c-47cd-86f6-5d5e3de16bc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219199
Listing Expiration 2026-12-31
Marketing Start 2025-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708525
Hyphenated Format 46708-525

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 ANDA219199 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-525-25) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

46708-525-25 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-525-25) / 25 mL in 1 VIAL, SINGLE-DOSE

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": "f8e001f5-441c-47cd-86f6-5d5e3de16bc0", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["f8e001f5-441c-47cd-86f6-5d5e3de16bc0"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (46708-525-25)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "46708-525-25", "marketing_start_date": "20250627"}], "brand_name": "doxorubicin hydrochloride", "product_id": "46708-525_f8e001f5-441c-47cd-86f6-5d5e3de16bc0", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "46708-525", "generic_name": "doxorubicin hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "doxorubicin hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA219199", "marketing_category": "ANDA", "marketing_start_date": "20250627", "listing_expiration_date": "20261231"}