Home NDC 0143-9308 Idarubicin Hydrochloride
Product NDC 0143-9308
11-digit product format 001439308
Labeler code 0143
Product ID 0143-9308_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 42 .
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.
Product history page 1 of 2 · 50 observed 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 2026-08-18 06:07:40 2026-07 A065275-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065275-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065275-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065275-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065275-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065275-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065275-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065275-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065275-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2006-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065275-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2006-12-14 d8e5a09893c0…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
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 0143-9308-01 Idarubicin Hydrochloride 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION 20 4 0143-9308-01 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 0143-9308 IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250109_7c20b574-285b-49eb-a98e-6752e4bb481d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 0143-9308-01 00143930801 1 VIAL, GLASS in 1 BOX (0143-9308-01) / 20 mL in 1 VIAL, GLASS 2018-01-12 0000-00-00 No No Current