Home NDC 71288-185 Idarubicin Hydrochloride
Product NDC 71288-185
11-digit product format 712880185
Labeler code 71288
Product ID 71288-185_677002b4-7b30-4d32-ae99-5ee630c5b5fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Idarubicin Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA065036
Marketing category ANDA
Marketing start 2025-06-01
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 A065036-001 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 A065036-002 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 A065036-003 IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01
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 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-001 IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-002 IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065036-003 IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2002-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065036-001 IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 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 71288-185-10 Idarubicin Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 71288-185-10 Idarubicin Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 1
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71288-185-10 71288018510 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-185-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2025-06-01 No No Current