Home NDC 0703-4156-11 Idarubicin Hydrochloride
Product NDC 0703-4156
Requested package NDC 0703-4156-11
11-digit product format 007034156
Labeler code 0703
Product ID 0703-4156_902aa4cb-c005-480e-8275-10145b8afefe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Idarubicin Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA065036
Marketing category ANDA
Marketing start 2002-10-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 47 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 2026-02-19 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…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065036-001 IDARUBICIN HYDROCHLORIDE PFS 1MG/ML INJECTABLE / INJECTION AP 2002-05-01 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IDARUBICIN HYDROCHLORIDE ACTIVE INGREDIENT 5VV3MDU5IE IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 IDARUBICIN ACTIVE MOIETY ZRP63D75JW IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-4156-11 00703415611 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-4156-11) > 20 mL in 1 VIAL, SINGLE-DOSE 2002-10-01 0000-00-00 No No Current