daunorubicin hydrochloride

Generic: daunorubicin hydrochloride

Labeler: hisun pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

daunorubicin hydrochloride 5 mg/mL

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-021
Product ID 42658-021_48b4337a-9cc5-665d-e063-6294a90a1613
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208759
Listing Expiration 2027-12-31
Marketing Start 2020-01-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658021
Hyphenated Format 42658-021

Supplemental Identifiers

RxCUI
309650 2002002
UPC
0342658021014 0342658019011
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 ANDA208759 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (42658-021-01) / 4 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (42658-021-02) / 4 mL in 1 VIAL
source: ndc

Packages (2)

42658-021-01 1 VIAL in 1 BOX (42658-021-01) / 4 mL in 1 VIAL 42658-021-02 10 VIAL in 1 CARTON (42658-021-02) / 4 mL in 1 VIAL

Ingredients (1)

daunorubicin hydrochloride (5 mg/mL)

Linked Drug Pages (2)

Daunorubicin Hydrochloride ndc-match (0.9) Daunorubicin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "48b4337a-9cc5-665d-e063-6294a90a1613", "openfda": {"upc": ["0342658021014", "0342658019011"], "unii": ["UD984I04LZ"], "rxcui": ["309650", "2002002"], "spl_set_id": ["9705fa12-499e-41a3-8fb4-f6df0858b851"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (42658-021-01)  / 4 mL in 1 VIAL", "package_ndc": "42658-021-01", "marketing_start_date": "20200120"}, {"sample": false, "description": "10 VIAL in 1 CARTON (42658-021-02)  / 4 mL in 1 VIAL", "package_ndc": "42658-021-02", "marketing_start_date": "20210127"}], "brand_name": "Daunorubicin Hydrochloride", "product_id": "42658-021_48b4337a-9cc5-665d-e063-6294a90a1613", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "42658-021", "generic_name": "daunorubicin hydrochloride", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daunorubicin Hydrochloride", "active_ingredients": [{"name": "DAUNORUBICIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA208759", "marketing_category": "ANDA", "marketing_start_date": "20200120", "listing_expiration_date": "20271231"}