Doxorubicin Hydrochloride

Product NDC: 0069-4030
Requested package NDC: 0069-4030-01
11-digit product format: 000694030
Labeler code: 0069
Product ID: 0069-4030_ec8915ea-6376-4904-8871-48156f963310
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxorubicin Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA050629
Marketing category: NDA
Marketing start: 2013-03-05
Marketing end: 2021-08-31
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: 0000-00-00
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	0069-4030	0069-4030-01	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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050629-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23
N050629-002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03
N050629-003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050629-001	AP
N050629-002	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 4 · 123 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	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-002	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1988-05-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-003	DOXORUBICIN HYDROCHLORIDE	150MG/75ML	INJECTABLE / INJECTION		RLD	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050629-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1987-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N050629-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050629-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050629-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050629-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050629-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050629-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050629-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050629-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050629-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050629-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050629-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050629-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050629-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050629-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050629-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050629-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050629-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050629-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050629-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050629-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050629-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050629-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050629-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050629-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050629-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050629-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050629-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050629-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050629-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050629-002	AP	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-4030-01	ML - Milliliter	0069-4030	d385eb07-7b30-4a7a-b8ea-b8da57b5eb76	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXORUBICIN HYDROCHLORIDE	ACTIVE INGREDIENT	82F2G7BL4E	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	3
DOXORUBICIN	ACTIVE MOIETY	80168379AG	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	3

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	1fd148fb-0fbc-4b6f-b790-23546fb46a71	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	00634b2b-4e48-4178-8877-28582af894ad	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Pfizer Laboratories Div Pfizer Inc	d31d7f58-66d0-4826-b6b5-5914c031965f	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050629 application number: NDA050629

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
0069-4030-01	00069403001	1 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-4030-01) > 5 mL in 1 VIAL, SINGLE-DOSE	2013-03-05	2021-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc \| Pfizer Inc \| Pfizer (Perth) Pty Ltd	2020-05-22	HUMAN PRESCRIPTION DRUG LABEL	13