Home NDC 0143-9307 Idarubicin Hydrochloride
Product NDC 0143-9307
11-digit product format 001439307
Labeler code 0143
Product ID 0143-9307_c78bf879-433f-4805-ad7b-5fa3002a75db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Idarubicin Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065275
Marketing category ANDA
Marketing start 2018-01-12
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 2026-12-31
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 A065275-001 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 A065275-002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 A065275-003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14
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 2024-10-29 15:01 UTC 2024-10 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A065275-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A065275-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A065275-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Idarubicin Hydrochloride
Listing expiration 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791493 Internal RxNorm lookup 1791498 Internal RxNorm lookup 1791500 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 0143-9307-01 Idarubicin Hydrochloride 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 4 0143-9307-01 Idarubicin Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9307 IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250109_7c20b574-285b-49eb-a98e-6752e4bb481d.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 0143-9307-01 00143930701 1 VIAL, GLASS in 1 BOX (0143-9307-01) / 10 mL in 1 VIAL, GLASS 2018-01-12 0000-00-00 No No Current