doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-883
Product ID 63323-883_89998b96-8ca7-4eb1-98a4-e533420d0e72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063277
Listing Expiration 2026-12-31
Marketing Start 2000-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323883
Hyphenated Format 63323-883

Supplemental Identifiers

RxCUI
1191138 1790097 1790099 1790100
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 ANDA063277 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-10) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

63323-883-05 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE 63323-883-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-10) / 10 mL in 1 VIAL, SINGLE-DOSE 63323-883-30 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30) / 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": "89998b96-8ca7-4eb1-98a4-e533420d0e72", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1191138", "1790097", "1790099", "1790100"], "spl_set_id": ["e0349f98-42fa-4003-b6d8-a1db1401b0ef"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-883-05", "marketing_start_date": "20000414"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-883-10", "marketing_start_date": "20000414"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-883-30", "marketing_start_date": "20000414"}], "brand_name": "Doxorubicin Hydrochloride", "product_id": "63323-883_89998b96-8ca7-4eb1-98a4-e533420d0e72", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-883", "generic_name": "DOXORUBICIN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin Hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA063277", "marketing_category": "ANDA", "marketing_start_date": "20000414", "listing_expiration_date": "20261231"}