Home NDC 0270-7097-08 LumaSon
Product NDC 0270-7097
Requested package NDC 0270-7097-08
11-digit product format 002707097
Labeler code 0270
Product ID 0270-7097_3ef95ad6-f22a-4baa-8f4a-1f6aaa4f7e21
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 SULFUR HEXAFLUORIDE; DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)
Active strength 60.7; .19; .19 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N203684-001 LUMASON 60.7MG/25MG FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-10-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203684-001 LUMASON 60.7MG/25MG FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-10-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203684-001 LUMASON 60.7MG/25MG FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-10-15 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 4 · 160 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203684-001 10232061 2038-07-06 Drug product 2019-03-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203684-001 10335502 2038-07-06 Drug product 2019-07-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203684-001 11723869 2039-05-15 U-3666 Drug product 2023-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203684-001 11723869 2039-05-15 U-3667 Drug product 2023-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203684-001 11723869 2039-05-15 U-3668 Drug product 2023-08-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203684-001 10232061 2038-07-06 Drug product 2019-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203684-001 10335502 2038-07-06 Drug product 2019-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203684-001 11723869 2039-05-15 U-3666 Drug product 2023-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203684-001 11723869 2039-05-15 U-3667 Drug product 2023-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203684-001 11723869 2039-05-15 U-3668 Drug product 2023-08-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203684-001 10232061 2038-07-06 Drug product 2019-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203684-001 10335502 2038-07-06 Drug product 2019-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203684-001 11723869 2039-05-15 U-3666 Drug product 2023-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203684-001 11723869 2039-05-15 U-3667 Drug product 2023-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203684-001 11723869 2039-05-15 U-3668 Drug product 2023-08-16 caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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 LumaSon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR HEXAFLUORIDE 60.7 mg/mg DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19 mg/mg SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg
DailyMed Product Concepts# 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 0270-7097-07 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 0270-7097-08 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 0270-7097-07 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 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 Strength 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 Socrata Ingredients# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0270-7097-08 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