doxorubicin hydrochloride

Generic: doxorubicin hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxorubicin hydrochloride
Generic Name doxorubicin hydrochloride
Labeler actavis pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxorubicin hydrochloride 2 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-733
Product ID 45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203622
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963733
Hyphenated Format 45963-733

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 ANDA203622 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (4)

45963-733-55 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE 45963-733-57 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE 45963-733-60 1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE 45963-733-68 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 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": "2ad7c99b-8cea-4e22-826f-9e49c90605b6", "openfda": {"unii": ["82F2G7BL4E"], "rxcui": ["1191138", "1790097", "1790099", "1790100"], "spl_set_id": ["33ddfdb1-b4bc-464d-a186-49c4b156279f"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-733-55", "marketing_start_date": "20141101"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-733-57", "marketing_start_date": "20141101"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60)  / 100 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "45963-733-60", "marketing_start_date": "20141101"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-733-68", "marketing_start_date": "20141101"}], "brand_name": "Doxorubicin hydrochloride", "product_id": "45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "45963-733", "generic_name": "Doxorubicin hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxorubicin hydrochloride", "active_ingredients": [{"name": "DOXORUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA203622", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}