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NDC 00270-7097-07 LumaSon .19; .19; 60.7 mg/mg; mg/mg; mg/mg Details
LumaSon .19; .19; 60.7 mg/mg; mg/mg; mg/mg
LumaSon is a INTRAVENOUS; INTRAVESICAL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BRACCO DIAGNOSTICS INC. The primary component is DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE.
Product Information
NDC | 00270-7097 |
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Product ID | 0270-7097_f2ac7c1e-74f0-9fb2-d158-5123798b89cc |
Associated GPIs | |
GCN Sequence Number | 059242 |
GCN Sequence Number Description | sulfur hexafluoride microsphr VIAL 25 MG INTRAVEN |
HIC3 | Z9D |
HIC3 Description | DIAGNOSTIC PREPARATIONS,MISCELLANEOUS |
GCN | 24815 |
HICL Sequence Number | 032972 |
HICL Sequence Number Description | SULFUR HEXAFLUORIDE MICROSPHERES |
Brand/Generic | Brand |
Proprietary Name | LumaSon |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | SULFUR HEXAFLUORIDE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION |
Route | INTRAVENOUS; INTRAVESICAL |
Active Ingredient Strength | .19; .19; 60.7 |
Active Ingredient Units | mg/mg; mg/mg; mg/mg |
Substance Name | DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL); SULFUR HEXAFLUORIDE |
Labeler Name | BRACCO DIAGNOSTICS INC |
Pharmaceutical Class | Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA203684 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00270-7097-07 (00270709707)
NDC Package Code | 0270-7097-07 |
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Billing NDC | 00270709707 |
Package | 20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL |
Marketing Start Date | 2021-04-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |