Doxorubicin Hydrochloride

Product NDC: 0069-0277
Requested package NDC: 0069-0277-02
11-digit product format: 000690277
Labeler code: 0069
Product ID: 0069-0277_68af240b-3f2d-450c-b2bf-6f12d5176562
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: 2024-08-19
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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0069-0277	0069-0277-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxorubicin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXORUBICIN HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82F2G7BL4E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191138	Internal RxNorm lookup
1790097	Internal RxNorm lookup
1790099	Internal RxNorm lookup
1790100	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1fd148fb-0fbc-4b6f-b790-23546fb46a71	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ee64805-1a32-49b4-a119-9376fc9e6633	Product name	5	20250305
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
750deab0-bb49-36cc-d493-bfaec857a32e	Product name	5	20190807
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-0277-02	Doxorubicin Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		28
0069-0277-02	Doxorubicin Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0277-02	ML - Milliliter	0069-0277	39501e19-d855-4b96-bd6c-3eafb27887f8	1	2024-09-09

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]	11
DOXORUBICIN	ACTIVE MOIETY	80168379AG	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	11
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-0277	DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	27	Current NDC, 2 package rows	20241121_1fd148fb-0fbc-4b6f-b790-23546fb46a71.zip

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 ndc (package): 0069-0277-02 ndc (product): 0069-0277 ndc11 (package): 00069027702
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790097	DOXOrubicin HCl 10 MG in 5 mL Injection	PSN	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1191138	DOXOrubicin HCl 2 MG/ML Injectable Solution	PSN	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790099	DOXOrubicin HCl 20 MG in 10 ML Injection	PSN	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790100	DOXOrubicin HCl 50 MG in 25 ML Injection	PSN	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790099	10 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790100	25 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790097	5 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1191138	doxorubicin hydrochloride 2 MG/ML Injectable Solution	SCD	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790097	doxorubicin hydrochloride 10 MG per 5 ML Injection	SY	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790099	doxorubicin hydrochloride 20 MG per 10 ML Injection	SY	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28
1790100	doxorubicin hydrochloride 50 MG per 25 ML Injection	SY	1fd148fb-0fbc-4b6f-b790-23546fb46a71	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0069-0277-02	00069027702	1 VIAL, SINGLE-DOSE in 1 CARTON (0069-0277-02) / 10 mL in 1 VIAL, SINGLE-DOSE	2024-08-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	Pfizer Laboratories Div Pfizer Inc	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	28