doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-250
Product ID 68083-250_b7814991-37d8-4928-ad83-d8fc04409c08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209825
Listing Expiration 2026-12-31
Marketing Start 2017-08-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083250
Hyphenated Format 68083-250

Supplemental Identifiers

RxCUI
1191138 1790097 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 ANDA209825 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-250-01) / 100 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-250-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-250-01) / 100 mL in 1 VIAL, MULTI-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": "b7814991-37d8-4928-ad83-d8fc04409c08", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1191138", "1790097", "1790127"], "spl_set_id": ["74b14803-afc8-4a2e-ba92-43f1a72025eb"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-250-01)  / 100 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-250-01", "marketing_start_date": "20170822"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "68083-250_b7814991-37d8-4928-ad83-d8fc04409c08", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68083-250", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA209825", "marketing_category": "ANDA", "marketing_start_date": "20170822", "listing_expiration_date": "20261231"}