doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTABLE, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-050
Product ID 47335-050_dc7b9af1-bb7c-45f8-8f2e-d03c6e22898e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203263
Listing Expiration 2026-12-31
Marketing Start 2013-02-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335050
Hyphenated Format 47335-050

Supplemental Identifiers

RxCUI
1790115 1790127
UPC
0347335050400
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 ANDA203263 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

47335-050-40 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40) / 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": "dc7b9af1-bb7c-45f8-8f2e-d03c6e22898e", "openfda": {"upc": ["0347335050400"], "unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["fbc48fa5-0bfb-4957-b13c-a56bb7a13b56"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "47335-050-40", "marketing_start_date": "20130205"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "47335-050_dc7b9af1-bb7c-45f8-8f2e-d03c6e22898e", "dosage_form": "INJECTABLE, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "47335-050", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA203263", "marketing_category": "ANDA", "marketing_start_date": "20130205", "listing_expiration_date": "20261231"}