daunorubicin hydrochloride

Generic: daunorubicin hydrochloride

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daunorubicin hydrochloride
Generic Name daunorubicin hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daunorubicin hydrochloride 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-182
Product ID 71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065035
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288182
Hyphenated Format 71288-182

Supplemental Identifiers

RxCUI
309650
UNII
UD984I04LZ

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 daunorubicin hydrochloride (source: ndc)
Generic Name daunorubicin hydrochloride (source: ndc)
Application Number ANDA065035 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)
source: ndc

Packages (1)

71288-182-05 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)

Ingredients (1)

daunorubicin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

daunorubicin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69", "openfda": {"unii": ["UD984I04LZ"], "rxcui": ["309650"], "spl_set_id": ["ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05)  / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)", "package_ndc": "71288-182-05", "marketing_start_date": "20250601"}], "brand_name": "daunorubicin hydrochloride", "product_id": "71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "71288-182", "generic_name": "daunorubicin hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daunorubicin hydrochloride", "active_ingredients": [{"name": "DAUNORUBICIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA065035", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}