Home NDC 0013-2576 Idamycin PFS
Product NDC 0013-2576
11-digit product format 000132576
Labeler code 0013
Product ID 0013-2576_d504ef4f-8fe8-447e-8fb3-30846fb2e486
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name idarubicin hydrochloride
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050734
Marketing category NDA
Marketing start 1997-02-17
Substance IDARUBICIN HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050734-001 IDAMYCIN PFS IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 N050734-002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 N050734-003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N050734-001 IDAMYCIN PFS 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N050734-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N050734-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1997-02-17 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Idamycin PFS IDARUBICIN HYDROCHLORIDE Pfizer Laboratories Div Pfizer Inc 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050734 application number: NDA050734 ndc (product): 0013-2576
Additional Listing Data#
Finished product Yes
Brand name base Idamycin PFS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IDARUBICIN HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5VV3MDU5IE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791493 Internal RxNorm lookup 1791495 Internal RxNorm lookup 1791498 Internal RxNorm lookup 1791499 Internal RxNorm lookup 1791500 Internal RxNorm lookup 1791501 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0013-2576-05 Idamycin PFS 1 in 1 CARTON SOLUTION 1 27 0013-2576-05 Idamycin PFS 5 mL in 1 VIAL, SINGLE-DOSE SOLUTION 5 27 0013-2576-91 Idamycin PFS 5 mL in 1 VIAL, SINGLE-DOSE SOLUTION 5 27 0013-2576-91 Idamycin PFS 1 in 1 CARTON SOLUTION 1 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0013-2576 IDAMYCIN PFS (IDARUBICIN HYDROCHLORIDE) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 25 Current NDC, Legacy NDC, 4 package rows 20240814_0a5a6d93-cc1e-4d7f-8da1-446c134503b3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0013-2576-05 00013257605 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-05) / 5 mL in 1 VIAL, SINGLE-DOSE 2024-08-12 No No Current 0013-2576-91 00013257691 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-2576-91) / 5 mL in 1 VIAL, SINGLE-DOSE 1997-02-17 2026-08-31 No No Current