Home NDC 0143-9551 Daunorubicin Hydrochloride
Product NDC 0143-9551
11-digit product format 001439551
Labeler code 0143
Product ID 0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daunorubicin Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA050731
Marketing category NDA
Marketing start 2018-01-02
Substance DAUNORUBICIN HYDROCHLORIDE
Active strength 5 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050731-001 DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050731-001 AP
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 · 43 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 2026-09-14 22:38:34 2026-08 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050731-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1998-01-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Daunorubicin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DAUNORUBICIN HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UD984I04LZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309650 Internal RxNorm lookup 2002002 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9551-01 Daunorubicin Hydrochloride 4 mL in 1 VIAL INJECTION 4 6 0143-9551-10 Daunorubicin Hydrochloride 10 in 1 BOX INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9551 DAUNORUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240216_227784a8-ce68-4dd4-8ac5-a65265969677.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9551-01 00143955101 4 mL in 1 VIAL 4 ml Historical 0143-9551-10 00143955110 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01) 10 vial 2018-01-02 0000-00-00 No No Current