idamycin pfs

Generic: idarubicin hydrochloride

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name idamycin pfs
Generic Name idarubicin hydrochloride
Labeler pfizer laboratories div pfizer inc
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

idarubicin hydrochloride 1 mg/mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0013-2596
Product ID 0013-2596_e50acac6-117c-4368-9357-a8c3c0940a52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050734
Listing Expiration 2027-12-31
Marketing Start 1997-02-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00132596
Hyphenated Format 0013-2596

Supplemental Identifiers

RxCUI
1791493 1791495 1791498 1791499 1791500 1791501
UNII
5VV3MDU5IE

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 idamycin pfs (source: ndc)
Generic Name idarubicin hydrochloride (source: ndc)
Application Number NDA050734 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-20) / 20 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-91) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0013-2596-20 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-20) / 20 mL in 1 VIAL, SINGLE-DOSE 0013-2596-91 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-91) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

idarubicin hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Idamycin PFS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e50acac6-117c-4368-9357-a8c3c0940a52", "openfda": {"unii": ["5VV3MDU5IE"], "rxcui": ["1791493", "1791495", "1791498", "1791499", "1791500", "1791501"], "spl_set_id": ["0a5a6d93-cc1e-4d7f-8da1-446c134503b3"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0013-2596-20", "marketing_start_date": "20240311"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2596-91)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0013-2596-91", "marketing_start_date": "19970217"}], "brand_name": "Idamycin PFS", "product_id": "0013-2596_e50acac6-117c-4368-9357-a8c3c0940a52", "dosage_form": "SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0013-2596", "generic_name": "idarubicin hydrochloride", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Idamycin PFS", "active_ingredients": [{"name": "IDARUBICIN HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA050734", "marketing_category": "NDA", "marketing_start_date": "19970217", "listing_expiration_date": "20271231"}