Lumason

Product NDC: 0270-7097
11-digit product format: 002707097
Labeler code: 0270
Product ID: 0270-7097_47b0f2df-0b6c-a221-750d-763d5ece665b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SULFUR HEXAFLUORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route: INTRAVENOUS; INTRAVESICAL
Labeler: BRACCO DIAGNOSTICS INC
Application: NDA203684
Marketing category: NDA
Marketing start: 2021-04-01
Substance: DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE
Active strength: .19; .19; 60.7 mg/mg; mg/mg; mg/mg
Pharmacologic classes: Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N203684-001	LUMASON	SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS		RLD, RS	2014-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203684-001	10232061	2038-07-06		Drug product	2019-03-25
N203684-001	10335502	2038-07-06		Drug product	2019-07-16
N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16
N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16
N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16

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	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203684-001	LUMASON	60.7MG/25MG	FOR SUSPENSION / INTRAVENOUS	RLD, RS	2014-10-15	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	10232061	2038-07-06		Drug product	2019-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	10335502	2038-07-06		Drug product	2019-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	11723869	2039-05-15	U-3666	Drug product	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	11723869	2039-05-15	U-3667	Drug product	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203684-001	11723869	2039-05-15	U-3668	Drug product	2023-08-16	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203684-001	NPP	2022-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203684-001	NPP	2022-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203684-001	NPP	2022-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203684-001	I-728	2019-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203684-001	NCE	2019-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203684-001	NPP	2022-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203684-001	NPP	2022-11-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203684-001	NPP	2022-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203684-001	NPP	2022-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203684-001	NPP	2022-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203684-001	NPP	2022-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203684-001	I-728	2019-03-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203684-001	NCE	2019-10-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203684-001	NPP	2022-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203684-001	I-728	2019-03-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203684-001	NCE	2019-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203684-001	I-728	2019-03-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203684-001	NCE	2019-10-10	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N203684-001	NPP	2022-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203684-001	NPP	2022-11-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203684-001	NPP	2022-11-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203684-001	NPP	2022-11-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203684-001	NPP	2022-11-13	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lumason
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFUR HEXAFLUORIDE	.19 mg/mg
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-	.19 mg/mg
SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)	60.7 mg/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WS7LR3I1D6	Internal UNII lookup
EAG959U971	Internal UNII lookup
841B886EJ7	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69822a55-226c-f133-e3b8-2b5826667c5b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8f6af59-3ac0-4f91-bbb3-7b013673234d	Product name	1	20170428

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
0270-7097-07	2022-08-26	e4f33bdf-aec0-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use LUMASON ® safely and effectively. See full prescribing information for LUMASON. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use Initial U.S. Approval: 2014
0270-7097-08	2022-08-26	e4f33bdf-9d4d-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use LUMASON ® safely and effectively. See full prescribing information for LUMASON. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use Initial U.S. Approval: 2014
0270-7097-07	2022-07-29	e4f33bdf-aec0-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use LUMASON ® safely and effectively. See full prescribing information for LUMASON. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use Initial U.S. Approval: 2014
0270-7097-08	2022-07-29	e4f33bdf-9d4d-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use LUMASON ® safely and effectively. See full prescribing information for LUMASON. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0270-7097-07	LumaSon	20 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	20	19
0270-7097-07	LumaSon	25 mg in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	25	19
0270-7097-08	Lumason	20 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	20	10
0270-7097-08	Lumason	25 mg in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	25	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-7097-07	EA - Each	0270-7097	5f9ed3f8-b290-480d-a0af-50b0e2764f17	1	2021-06-02
0270-7097-08	EA - Each	0270-7097	eb1f53fc-9f96-4ba8-8f2a-ef5d443ca176	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALT	ACTIVE INGREDIENT	841B886EJ7	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-	ACTIVE INGREDIENT	EAG959U971	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
SULFUR HEXAFLUORIDE	ACTIVE INGREDIENT	WS7LR3I1D6	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALT	ACTIVE MOIETY	841B886EJ7	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
DISTEAROYLPHOSPHATIDYLCHOLINE, DL-	ACTIVE MOIETY	EAG959U971	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
SULFUR HEXAFLUORIDE	ACTIVE MOIETY	WS7LR3I1D6	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LUMASON (SULFUR HEXAFLUORIDE) KIT [BRACCO DIAGNOSTICS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0270-7097	LUMASON (SULFUR HEXAFLUORIDE) KIT LUMASON (SULFUR HEXAFLUORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BRACCO DIAGNOSTICS INC]	18	Current NDC, Legacy NDC, 2 package rows	20230817_7c679424-c3f7-ed02-892f-20ca0d775089.zip
0270-7097	LUMASON (SULFUR HEXAFLUORIDE) KIT LUMASON (SULFUR HEXAFLUORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [BRACCO DIAGNOSTICS INC]	9	Current NDC, Legacy NDC, 2 package rows	20231128_69822a55-226c-f133-e3b8-2b5826667c5b.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
Lumason	SULFUR HEXAFLUORIDE	BRACCO DIAGNOSTICS INC	69822a55-226c-f133-e3b8-2b5826667c5b	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203684 application number: NDA203684 ndc (product): 0270-7097
LumaSon	SULFUR HEXAFLUORIDE	BRACCO DIAGNOSTICS INC	7c679424-c3f7-ed02-892f-20ca0d775089	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203684 application number: NDA203684 ndc (product): 0270-7097

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EAG959U971	DISTEAROYLPHOSPHATIDYLCHOLINE, DL-	4539-70-2	DISTEAROYLPHOSPHATIDYLCHOLINE, DL-
841B886EJ7	SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)	200880-41-7	SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)
WS7LR3I1D6	SULFUR HEXAFLUORIDE	2551-62-4	SULFUR HEXAFLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-7097-07	00270709707	20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL	20 vial	2021-04-01	0000-00-00	No	No	Current
0270-7097-08	00270709708	20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL	20 vial	2021-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LumaSon	BRACCO DIAGNOSTICS INC \| Bracco Suisse SA \| AIRGAS THERAPEUTICS LLC \| Bracco Imaging SPA \| Lipoid GmbH	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	10
LumaSon	BRACCO DIAGNOSTICS INC \| Bracco Suisse SA \| Vetter Pharma-Fertigung GmbH & Co. KG \| Bracco Imaging SPA \| Lipoid GmbH	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	19