Doxorubicin Hydrochloride

Product NDC: 70860-208
Requested package NDC: 70860-208-25
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-208	70860-208-25	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209825-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209825-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209825-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209825-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209825-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209825-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209825-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209825-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209825-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209825-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209825-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209825-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209825-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209825-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209825-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209825-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209825-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209825-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209825-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209825-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209825-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209825-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209825-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209825-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209825-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209825-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209825-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209825-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209825-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209825-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209825-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209825-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209825-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209825-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209825-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209825-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209825-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209825-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209825-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209825-001	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70860-208-05	2025-02-03	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
70860-208-25	2025-02-03	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
70860-208-51	2025-02-03	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
70860-208-05	2024-01-30	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
70860-208-25	2024-01-30	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974
70860-208-51	2024-01-30	These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE INJECTION. DOXORUBICIN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1974

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-208-05	ML - Milliliter	70860-208	07f5c428-d72d-488c-a051-e3944f954305	1	2018-01-12
70860-208-25	ML - Milliliter	70860-208	b5a234b1-39ae-4f29-a490-f2eb41c0b3fc	1	2018-01-12
70860-208-51	ML - Milliliter	70860-208	393261bf-1715-4fc1-8992-032213977d3e	1	2018-01-12

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Sagent Pharmaceuticals	ae80bd3a-b99a-4e01-a444-b9d05687f00e	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209825 application number: ANDA209825
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Gland Pharma Limited	74b14803-afc8-4a2e-ba92-43f1a72025eb	2024-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209825 application number: ANDA209825

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82F2G7BL4E	DOXORUBICIN HYDROCHLORIDE	25316-40-9	DOXORUBICIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	Athenex Pharmaceutical Division, LLC.	2017-10-20	HUMAN PRESCRIPTION DRUG LABEL	1