Home NDC 70860-208 Doxorubicin Hydrochloride
Product NDC 70860-208
11-digit product format 708600208
Labeler code 70860
Product ID 70860-208_93ce419e-e621-46a8-9e35-b818a569a18a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxorubicin hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA209825
Marketing category ANDA
Marketing start 2017-10-20
Marketing end 0000-00-00
Substance DOXORUBICIN HYDROCHLORIDE
Active strength 2 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70860-208-51 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70860-208-25 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70860-208-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70860-208-51 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70860-208-25 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70860-208-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70860-208-51 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70860-208-25 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70860-208-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70860-208-51 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70860-208-25 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70860-208-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70860-208-51 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70860-208-25 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70860-208-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70860-208-51 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70860-208-25 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70860-208-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70860-208-25 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70860-208-51 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70860-208-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70860-208-25 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70860-208-51 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70860-208-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70860-208-25 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70860-208-51 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70860-208-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70860-208-25 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70860-208-51 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70860-208-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70860-208-25 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70860-208-51 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70860-208-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70860-208-25 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70860-208-51 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70860-208-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70860-208-25 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70860-208-51 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70860-208-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70860-208-25 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70860-208-51 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70860-208-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70860-208-25 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70860-208-51 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70860-208-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209825-001 DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209825-001 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 · 41 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 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209825-001 DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE / INJECTION AP 2017-08-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70860-208-05 70860020805 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-208-05) > 5 mL in 1 VIAL, SINGLE-DOSE 2017-10-20 0000-00-00 No No Current 70860-208-25 70860020825 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-208-25) > 25 mL in 1 VIAL, SINGLE-DOSE 2017-10-20 0000-00-00 No No Current 70860-208-51 70860020851 1 VIAL, MULTI-DOSE in 1 CARTON (70860-208-51) > 100 mL in 1 VIAL, MULTI-DOSE 2017-10-20 0000-00-00 No No Current