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 INJECTION, SUSPENSION, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-629
Product ID 68001-629_28d93c64-a421-37e6-e063-6294a90ab77d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215178
Listing Expiration 2026-12-31
Marketing Start 2025-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001629
Hyphenated Format 68001-629

Supplemental Identifiers

RxCUI
1790115 1790127
UPC
0368001629362 0368001629263
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 ANDA215178 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (68001-629-26) / 25 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (68001-629-36) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

68001-629-26 1 VIAL, SINGLE-USE in 1 CARTON (68001-629-26) / 25 mL in 1 VIAL, SINGLE-USE 68001-629-36 1 VIAL, SINGLE-USE in 1 CARTON (68001-629-36) / 10 mL in 1 VIAL, SINGLE-USE

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": "28d93c64-a421-37e6-e063-6294a90ab77d", "openfda": {"upc": ["0368001629362", "0368001629263"], "unii": ["82F2G7BL4E"], "rxcui": ["1790115", "1790127"], "spl_set_id": ["b8b66e93-0813-4876-b291-8d7c36a99807"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68001-629-26)  / 25 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68001-629-26", "marketing_start_date": "20250107"}, {"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (68001-629-36)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68001-629-36", "marketing_start_date": "20250107"}], "brand_name": "DOXORUBICIN HYDROCHLORIDE", "product_id": "68001-629_28d93c64-a421-37e6-e063-6294a90ab77d", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68001-629", "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": "ANDA215178", "marketing_category": "ANDA", "marketing_start_date": "20250107", "listing_expiration_date": "20261231"}