Home NDC 0703-5233 daunorubicin hydrochloride
Product NDC 0703-5233
11-digit product format 007035233
Labeler code 0703
Product ID 0703-5233_78928bf7-c736-4d9a-8137-a0a5c0653540
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daunorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA065035
Marketing category ANDA
Marketing start 2004-04-01
Marketing end 0000-00-00
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 2020-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0703-5233-13 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0703-5233-93 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0703-5233-13 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0703-5233-93 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0703-5233-13 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0703-5233-93 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0703-5233-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0703-5233-93 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0703-5233-13 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0703-5233-93 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0703-5233-13 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0703-5233-93 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0703-5233-13 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0703-5233-93 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0703-5233-13 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0703-5233-93 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0703-5233-13 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0703-5233-93 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0703-5233-13 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0703-5233-93 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0703-5233-13 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0703-5233-93 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0703-5233-13 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0703-5233-93 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DAUNORUBICIN HYDROCHLORIDE ACTIVE INGREDIENT UD984I04LZ DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 DAUNORUBICIN ACTIVE MOIETY ZS7284E0ZP DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4
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 0703-5233-13 00703523313 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-5233-13) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-11) 2004-04-01 0000-00-00 No No Current