Doxorubicin Hydrochloride

Product NDC: 16714-742
11-digit product format: 167140742
Labeler code: 16714
Product ID: 16714-742_515391d8-92bc-84e3-2408-79a2d0b35ed2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxorubicin Hydrochloride
Dosage form: INJECTABLE, LIPOSOMAL
Route: INTRAVENOUS
Labeler: NorthStar RxLLC
Application: ANDA208657
Marketing category: ANDA
Marketing start: 2017-08-29
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

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	16714-742		D	Discontinued by firm		2026-08-03
excluded package	package	16714-742	16714-742-01	D	Discontinued by firm		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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2017-05-15
A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2017-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208657-001	AB
A208657-002	AB

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 3 · 82 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	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208657-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208657-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2017-05-15	`782e0a99824c…`

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	A208657-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208657-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208657-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208657-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208657-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208657-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208657-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208657-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208657-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208657-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208657-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208657-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208657-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208657-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208657-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208657-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208657-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208657-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208657-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208657-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208657-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208657-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208657-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208657-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208657-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208657-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208657-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208657-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208657-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208657-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208657-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208657-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208657-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208657-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208657-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208657-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208657-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208657-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208657-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208657-002	AB	1	`782e0a99824c…`

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-742-01	Doxorubicin Hydrochloride	1 in 1 CARTON	INJECTABLE, LIPOSOMAL	1		6
16714-742-01	Doxorubicin Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTABLE, LIPOSOMAL	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-742-01	ML - Milliliter	16714-742	dd9a772b-2975-4cde-a0fc-6fdd309f1d2d	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-742	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [NORTHSTAR RXLLC]	6	Current NDC, Legacy NDC, 2 package rows	20230411_67417a18-e0f4-c9a0-e152-b8d8dc934af6.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	BluePoint Laboratories	f1a12eb5-5bdc-45f4-843e-0c971535b184	2022-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208657 application number: ANDA208657

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
1790115	DOXOrubicin HCl liposome 20 MG in 10 ML Injection	PSN	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6
1790127	DOXOrubicin HCl liposome 50 MG in 25 ML Injection	PSN	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6
1790115	10 ML doxorubicin hydrochloride liposome 2 MG/ML Injection	SCD	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6
1790127	25 ML doxorubicin hydrochloride liposome 2 MG/ML Injection	SCD	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6
1790115	doxorubicin hydrochloride liposome 20 MG per 10 ML Injection	SY	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6
1790127	doxorubicin hydrochloride liposome 50 MG per 25 ML Injection	SY	67417a18-e0f4-c9a0-e152-b8d8dc934af6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-742-01	16714074201	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-742-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2017-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	NorthStar RxLLC \| Dr. Reddy's Laboratories Limited \| Natco Pharma Ltd	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	6