Home NDC 42658-021-91 Daunorubicin Hydrochloride
Product NDC 42658-021
Requested package NDC 42658-021-91
11-digit product format 426580021
Labeler code 42658
Product ID 42658-021_48b4337a-9cc5-665d-e063-6294a90a1613
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daunorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA208759
Marketing category ANDA
Marketing start 2020-01-20
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 2027-12-31
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 A208759-001 DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208759-001 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 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208759-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2019-04-12 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 2027-12-31 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 42658-021-01 Daunorubicin Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 13 42658-021-01 Daunorubicin Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 13 42658-021-02 Daunorubicin Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 13 42658-021-02 Daunorubicin Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 13 42658-021-91 Daunorubicin Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 4 42658-021-91 Daunorubicin Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 4 42658-021-92 Daunorubicin Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 4 42658-021-92 Daunorubicin Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42658-021 DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] 12 Current NDC, Legacy NDC, 4 package rows 20241227_9705fa12-499e-41a3-8fb4-f6df0858b851.zip 42658-021 DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20230209_f4312095-3c21-296b-e053-2995a90a0d9c.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 Units Marketing start Sample Exclude flag Status 42658-021-91 42658002191 1 VIAL in 1 BOX (42658-021-91) / 4 mL in 1 VIAL 1 vial 2023-01-15 No No Current