doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler zydus lifesciences limited
Dosage Form INJECTABLE, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 49315-009
Product ID 49315-009_2c0f5abf-ca66-445c-9a35-e39b2111911e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212299
Listing Expiration 2026-12-31
Marketing Start 2020-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49315009
Hyphenated Format 49315-009

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 ANDA212299 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

49315-009-07 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07) / 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": "2c0f5abf-ca66-445c-9a35-e39b2111911e", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["bad467d4-7e27-4eda-b4d3-854460f0adab"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "49315-009-07", "marketing_start_date": "20200914"}], "brand_name": "DOXORUBICIN HYDROCHLORIDE", "product_id": "49315-009_2c0f5abf-ca66-445c-9a35-e39b2111911e", "dosage_form": "INJECTABLE, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "49315-009", "generic_name": "doxorubicin hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXORUBICIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA212299", "marketing_category": "ANDA", "marketing_start_date": "20200914", "listing_expiration_date": "20261231"}