Doxorubicin Hydrochloride

Product NDC: 47335-049
11-digit product format: 473350049
Labeler code: 47335
Product ID: 47335-049_efff8fef-d079-4581-8027-646e57a23c62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxorubicin Hydrochloride
Dosage form: INJECTABLE, LIPOSOMAL
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA203263
Marketing category: ANDA
Marketing start: 2013-02-05
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 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
A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04
A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203263-001	AB
A203263-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203263-001	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203263-002	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AB	RS	2013-02-04	`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	A203263-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203263-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203263-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203263-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203263-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203263-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203263-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203263-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203263-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203263-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203263-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203263-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203263-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203263-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203263-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203263-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203263-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203263-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203263-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203263-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203263-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203263-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203263-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203263-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203263-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203263-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203263-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203263-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203263-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203263-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203263-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203263-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203263-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203263-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203263-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203263-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203263-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203263-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203263-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203263-002	AB	1	`782e0a99824c…`

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
fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	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
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
47335-049-40	Doxorubicin Hydrochloride	1 in 1 PACKAGE	INJECTABLE, LIPOSOMAL	1		24
47335-049-40	Doxorubicin Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTABLE, LIPOSOMAL	10		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-049-40	ML - Milliliter	47335-049	cd366c2a-021c-49e9-9e32-4b4818108cdf	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXORUBICIN HYDROCHLORIDE	ACTIVE INGREDIENT	82F2G7BL4E	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
DOXORUBICIN	ACTIVE MOIETY	80168379AG	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
AMMONIUM SULFATE	INACTIVE INGREDIENT	SU46BAM238	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
HYDROGENATED SOYBEAN LECITHIN	INACTIVE INGREDIENT	H1109Z9J4N	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT	INACTIVE INGREDIENT	3L6NN8ZZKU	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMA GLOBAL FZE]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-049	DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.]	23	Current NDC, Legacy NDC, 2 package rows	20250411_fbc48fa5-0bfb-4957-b13c-a56bb7a13b56.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	BluePoint Laboratories	f6508535-e7a7-4e50-8d0c-43deda8d0d08	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203263 application number: ANDA203263
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	NorthStar RxLLC	ddf55319-bf62-4ec7-8be2-ef97188837c4	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203263 application number: ANDA203263
Doxorubicin Hydrochloride	DOXORUBICIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203263 application number: ANDA203263 ndc (product): 47335-049

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	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24
1790127	DOXOrubicin HCl liposome 50 MG in 25 ML Injection	PSN	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24
1790115	10 ML doxorubicin hydrochloride liposome 2 MG/ML Injection	SCD	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24
1790127	25 ML doxorubicin hydrochloride liposome 2 MG/ML Injection	SCD	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24
1790115	doxorubicin hydrochloride liposome 20 MG per 10 ML Injection	SY	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24
1790127	doxorubicin hydrochloride liposome 50 MG per 25 ML Injection	SY	fbc48fa5-0bfb-4957-b13c-a56bb7a13b56	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-049-40	47335004940	1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-049-40) / 10 mL in 1 VIAL, SINGLE-DOSE	2013-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxorubicin Hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-04-06	Human Prescription Drug Label	24