Adriamycin

Product NDC: 0143-9369
11-digit product format: 001439369
Labeler code: 0143
Product ID: 0143-9369_64517d03-d04d-40ed-8627-afcae0b156bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxorubicin Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA062975
Marketing category: ANDA
Marketing start: 1996-05-01
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	0143-9369		I	Inactivated by FDA		2026-08-03
excluded package	package	0143-9369	0143-9369-01	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062975-001	DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP		1989-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062975-001	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	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062975-001	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	1989-03-17	`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	A062975-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062975-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062975-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062975-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062975-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062975-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062975-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062975-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062975-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062975-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062975-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062975-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062975-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062975-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062975-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062975-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062975-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062975-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062975-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062975-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062975-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062975-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062975-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062975-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062975-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062975-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062975-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062975-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062975-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062975-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062975-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062975-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062975-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062975-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062975-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062975-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062975-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062975-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062975-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062975-001	AP	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0143-9369-01	2026-01-29	C162847	48780-1	49896155-aa40-586f-e063-e6dba90add90	These highlights do not include all the information needed to use ADRIAMYCIN (DOXOrubicin HCl) safely and effectively. See full prescribing information for ADRIAMYCIN ( Doxorubicin HCl) . ADRIAMYCIN (DOXOrubicin HCl) Injection, USP, for intravenous use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9369-01	Adriamycin	1 in 1 BOX	INJECTION, SOLUTION	1		3
0143-9369-01	Adriamycin	5 mL in 1 VIAL	INJECTION, SOLUTION	5		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9369-01	ML - Milliliter	0143-9369	bc54baf4-a35c-44ef-8e60-1678e6225dfa	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9369	ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	3	Legacy NDC, 2 package rows	20240413_b05d7515-2179-4f4b-b37e-dccc77127f8f.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 · 2 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.	36924f82-6c05-4989-9f41-a398c0ad48e6	2024-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062975 application number: ANDA062975
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	971de64b-ff09-4370-afd9-6eb1093ad27d	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062975 application number: ANDA062975

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
1799305	ADRIAMYCIN 10 MG in 5 ML Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799310	ADRIAMYCIN 2 MG/ML Injectable Solution	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799308	ADRIAMYCIN 20 MG in 10 ML Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799307	ADRIAMYCIN 50 MG in 25 ML Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790097	DOXOrubicin HCl 10 MG in 5 mL Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1191138	DOXOrubicin HCl 2 MG/ML Injectable Solution	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790099	DOXOrubicin HCl 20 MG in 10 ML Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790100	DOXOrubicin HCl 50 MG in 25 ML Injection	PSN	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799308	10 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]	SBD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799307	25 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]	SBD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799305	5 ML doxorubicin hydrochloride 2 MG/ML Injection [Adriamycin]	SBD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799310	doxorubicin hydrochloride 2 MG/ML Injectable Solution [Adriamycin]	SBD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790099	10 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790100	25 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790097	5 ML doxorubicin hydrochloride 2 MG/ML Injection	SCD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1191138	doxorubicin hydrochloride 2 MG/ML Injectable Solution	SCD	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799305	5 ML Adriamycin 2 MG/ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799310	Adriamycin 2 MG/ML Injectable Solution	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799308	ADRIAMYCIN 20 MG per 10 ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1799307	ADRIAMYCIN 50 MG per 25 ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790097	doxorubicin hydrochloride 10 MG per 5 ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790099	doxorubicin hydrochloride 20 MG per 10 ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3
1790100	doxorubicin hydrochloride 50 MG per 25 ML Injection	SY	b05d7515-2179-4f4b-b37e-dccc77127f8f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9369-01	00143936901	1 VIAL in 1 BOX (0143-9369-01) > 5 mL in 1 VIAL	1 vial	2019-10-01	0000-00-00	No	No	Current