doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler bluepoint laboratories
Dosage Form INJECTABLE, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-345
Product ID 68001-345_e9b9ead5-4033-1599-e053-2a95a90a0d81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208657
Listing Expiration 2026-12-31
Marketing Start 2018-02-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001345
Hyphenated Format 68001-345

Supplemental Identifiers

RxCUI
1790115 1790127
UPC
0368001345361 0368001345262
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 ANDA208657 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

68001-345-26 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSE 68001-345-36 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36) / 10 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": "e9b9ead5-4033-1599-e053-2a95a90a0d81", "openfda": {"upc": ["0368001345361", "0368001345262"], "unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["f1a12eb5-5bdc-45f4-843e-0c971535b184"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-345-26", "marketing_start_date": "20180216"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-345-36", "marketing_start_date": "20180216"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "68001-345_e9b9ead5-4033-1599-e053-2a95a90a0d81", "dosage_form": "INJECTABLE, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68001-345", "generic_name": "Doxorubicin Hydrochloride", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA208657", "marketing_category": "ANDA", "marketing_start_date": "20180216", "listing_expiration_date": "20261231"}