doxorubicin hydrochloride

Product NDC: 68001-706
Requested package NDC: 68001-706-36
11-digit product format: 680010706
Labeler code: 68001
Product ID: 68001-706_558895f3-e5b3-8e4e-e063-6294a90ad078
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxorubicin hydrochloride
Dosage form: INJECTION, SUSPENSION, LIPOSOMAL
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA219199
Marketing category: ANDA
Marketing start: 2026-07-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2025-06-27
A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB		2025-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219199-001	AB
A219199-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219199-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219199-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	2025-06-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219199-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219199-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219199-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219199-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219199-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219199-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219199-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219199-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219199-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219199-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219199-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219199-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790115	Internal RxNorm lookup
1790127	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
55889588-c5f1-d9bc-e063-6294a90a5791	Available on FDA.report

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	BluePoint Laboratories	55889588-c5f1-d9bc-e063-6294a90a5791	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219199 application number: ANDA219199 ndc (package): 68001-706-36 ndc (product): 68001-706 ndc11 (package): 68001070636
doxorubicin hydrochloride	DOXORUBICIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	f8e001f5-441c-47cd-86f6-5d5e3de16bc0	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219199 application number: ANDA219199

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82F2G7BL4E	DOXORUBICIN HYDROCHLORIDE	25316-40-9	DOXORUBICIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68001-706-36	68001070636	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-706-36) / 10 mL in 1 VIAL, SINGLE-DOSE	2026-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxorubicin hydrochloride	BluePoint Laboratories \| Dr. Reddy's Laboratories Inc. \| Alembic Pharmaceuticals Limited	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	1