Home NDC 71288-182 daunorubicin hydrochloride
Product NDC 71288-182
11-digit product format 712880182
Labeler code 71288
Product ID 71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daunorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA065035
Marketing category ANDA
Marketing start 2025-06-01
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 A065035-001 DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065035-001 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 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065035-001 DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-01-24 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309650 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 71288-182-04 daunorubicin hydrochloride 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 4 1 71288-182-05 daunorubicin hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 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 Units Marketing start Sample Exclude flag Status 71288-182-04 71288018204 4 mL in 1 VIAL, SINGLE-DOSE 4 ml Historical 71288-182-05 71288018205 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04) 2025-06-01 No No Current