Xofigo

Product NDC: 50419-208
11-digit product format: 504190208
Labeler code: 50419
Product ID: 50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Radium Ra 223 dichloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA203971
Marketing category: NDA
Marketing start: 2013-05-20
Substance: RADIUM RA-223 DICHLORIDE
Active strength: 30 uCi/mL
Pharmacologic classes: Radioactive alpha-Particle Emitting Therapeutic Agent [EPC], alpha-Particle Emitting Activity [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203971-001	XOFIGO	RADIUM RA-223 DICHLORIDE	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-05-15

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203971-001	XOFIGO	162mCi/6ML (27mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2013-05-15	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203971-001	6635234	2022-11-17	U-2271	2013-06-11	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Xofigo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RADIUM RA-223 DICHLORIDE	30 uCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RJ00KV3VTG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1424214	Internal RxNorm lookup
1424219	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
a398400e-bd31-41a9-9696-4f7c06569ede	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
73b7ef70-1c62-4735-8f63-18ac11c2ea54	Product name	2	20160502

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50419-208-01	2024-01-30	C162847	48780-1	1030e365-06cd-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use XOFIGO safely and effectively. See full prescribing information for XOFIGO. XOFIGO (radium Ra 223 dichloride) injection, for intravenous use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50419-208-01	Xofigo	6 mL in 1 VIAL, SINGLE-DOSE	INJECTION	6		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-208-01	EA - Each	50419-208	41fa4ad1-9fa2-4bf0-adbf-ed0f3f3ef2bf	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RADIUM CHLORIDE RA-223	ACTIVE INGREDIENT	RJ00KV3VTG	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1
RADIUM	ACTIVE MOIETY	W90AYD6R3Q	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-208	XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240704_a398400e-bd31-41a9-9696-4f7c06569ede.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
Xofigo	RADIUM RA 223 DICHLORIDE	Bayer HealthCare Pharmaceuticals Inc.	a398400e-bd31-41a9-9696-4f7c06569ede	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203971 application number: NDA203971 ndc (product): 50419-208

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RJ00KV3VTG	RADIUM RA-223 DICHLORIDE	444811-40-9	RADIUM RA-223 DICHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1424214	radium Ra-223 1100 kBq/ML in 6 ML Injection	PSN	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424219	Xofigo 1100 kBq/ML in 6 ML Injection	PSN	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424219	6 ML radium chloride Ra-223 30 MCI/ML Injection [Xofigo]	SBD	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424214	6 ML radium chloride Ra-223 30 MCI/ML Injection	SCD	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424214	radium Ra-223 dichloride 178 MCI per 6 ML Injection	SY	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424214	radium Ra-223 dichloride 6600 kBq per 6 ML Injection	SY	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424219	Xofigo (radium Ra-223 dichloride) 6600 kBq per 6 ML Injection	SY	a398400e-bd31-41a9-9696-4f7c06569ede	17
1424219	Xofigo 178 MCI per 6 ML Injection	SY	a398400e-bd31-41a9-9696-4f7c06569ede	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-208-01	50419020801	6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)	6 ml	2013-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xofigo	Bayer HealthCare Pharmaceuticals Inc. \| Cardinal Health 414, LLC \| Agilera Pharma AS	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	17