Doxorubicin Hydrochloride

Product NDC: 0143-9093
11-digit product format: 001439093
Labeler code: 0143
Product ID: 0143-9093_3b0d5f19-5eab-4729-8fbf-3b988cbc6d04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxorubicin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA062921
Marketing category: ANDA
Marketing start: 2018-01-19
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: 2026-12-31
Current FDA listing: Yes

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
A062921-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17
A062921-002	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17
A062921-003	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062921-002	AP
A062921-003	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	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-002	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-003	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE / INJECTION	AP	RS	1989-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062921-001	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE / INJECTION		RS	1989-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 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	A062921-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062921-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062921-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062921-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062921-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062921-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062921-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062921-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062921-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062921-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062921-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062921-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062921-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062921-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062921-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062921-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062921-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062921-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062921-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062921-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062921-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062921-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062921-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062921-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062921-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062921-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062921-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062921-003	AP	1	`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxorubicin Hydrochloride
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790095	Internal RxNorm lookup
1790103	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
f62aa88d-1e25-4049-87ec-99d42edd1d31	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
750deab0-bb49-36cc-d493-bfaec857a32e	Product name	5	20190807

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9093-01	Doxorubicin Hydrochloride	25 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	25		3
0143-9093-01	Doxorubicin Hydrochloride	1 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9093-01	EA - Each	0143-9093	52de5065-878b-429e-a991-83d811bf7886	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9093	DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240427_f62aa88d-1e25-4049-87ec-99d42edd1d31.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	f62aa88d-1e25-4049-87ec-99d42edd1d31	2024-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062921 application number: ANDA062921 ndc (product): 0143-9093

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
1790103	DOXOrubicin HCl 10 MG Injection	PSN	f62aa88d-1e25-4049-87ec-99d42edd1d31	3
1790095	DOXOrubicin HCl 50 MG Injection	PSN	f62aa88d-1e25-4049-87ec-99d42edd1d31	3
1790103	doxorubicin hydrochloride 10 MG Injection	SCD	f62aa88d-1e25-4049-87ec-99d42edd1d31	3
1790095	doxorubicin hydrochloride 50 MG Injection	SCD	f62aa88d-1e25-4049-87ec-99d42edd1d31	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9093-01	00143909301	1 VIAL in 1 BOX (0143-9093-01) / 25 mL in 1 VIAL	1 vial	2018-01-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	Hikma Pharmaceuticals USA Inc.	2024-04-26	HUMAN PRESCRIPTION DRUG LABEL	3