Adriamycin

Product NDC: 0143-9275
11-digit product format: 001439275
Labeler code: 0143
Product ID: 0143-9275_79560e42-fedf-48d0-b2f9-db8b1feacf0b
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
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0143-9275		I	Inactivated by FDA		2026-08-03
excluded package	package	0143-9275	0143-9275-01	I	Inactivated by FDA		2026-08-03

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…`

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
0143-9275-01	Adriamycin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		7
0143-9275-01	Adriamycin	1 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9275-01	EA - Each	0143-9275	2f034010-991f-4958-88e7-5e3fd0dbb05c	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9275	ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	7	Legacy NDC, 2 package rows	20240413_090bc1b1-3dc2-408d-94e6-48d2a3d4426c.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

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
2001102	ADRIAMYCIN 10 MG Injection	PSN	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
2001100	ADRIAMYCIN 50 MG Injection	PSN	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
1790103	DOXOrubicin HCl 10 MG Injection	PSN	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
1790095	DOXOrubicin HCl 50 MG Injection	PSN	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
2001102	doxorubicin hydrochloride 10 MG Injection [Adriamycin]	SBD	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
2001100	doxorubicin hydrochloride 50 MG Injection [Adriamycin]	SBD	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
1790103	doxorubicin hydrochloride 10 MG Injection	SCD	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
1790095	doxorubicin hydrochloride 50 MG Injection	SCD	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
2001102	Adriamycin 10 MG Injection	SY	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7
2001100	Adriamycin 50 MG Injection	SY	090bc1b1-3dc2-408d-94e6-48d2a3d4426c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9275-01	00143927501	1 VIAL in 1 BOX (0143-9275-01) > 5 mL in 1 VIAL	1 vial	2018-01-19	0000-00-00	No	No	Current