Prescription drug · NDA
Definity Rt (Perflutren) NDC 11994-017
Perflutren 6.52 mg/mL · Injection, Suspension · Intravenous · Lantheus Medical Imaging, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11994-017-01 | 1199400170111994001701 | 1 VIAL, GLASS in 1 CARTON (11994-017-01) / .35 mL in 1 VIAL, GLASSMarketed from Oct 1, 2020 | |
| 11994-017-20 | 1199400172011994001720 | 20 VIAL, GLASS in 1 CARTON (11994-017-20) / .35 mL in 1 VIAL, GLASSMarketed from Oct 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Definity Rt
- Generic name (nonproprietary)
- perflutren
- Active ingredients
- Perflutren — 6.52 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- Lantheus Medical Imaging, Inc.NDC labeler code 11994
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021064
- Marketing start
- Listing expires
- Other FDA classes
- Ultrasound Contrast Activity (Mechanism)
- Identifiers
- Product ID 11994-017_4d13e254-dcc7-460c-9adc-1c812562cef7SPL ID 4d13e254-dcc7-460c-9adc-1c812562cef7SPL set ID 7b9de6ab-a3ac-40c9-8103-139dc7a464a2UNII CK0N3WH0SR
- Pharmacologic class
- Contrast Agent for Ultrasound Imaging
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N411994001701followed by a unit qualifier and the quantityPackage 11994-0017-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 11994-017
- What is NDC 11994-017?
- 11994-017 is the product NDC for Definity Rt (perflutren), Perflutren 6.52 mg/mL injection, suspension, listed with the FDA by Lantheus Medical Imaging, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Definity Rt (Perflutren).
- What is the active ingredient?
- Perflutren.
- Who is the labeler?
- Lantheus Medical Imaging, Inc., NDC labeler code 11994. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Definity Rt?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 021064
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Definityperflutren | Perflutren 6.52 mg/mL | Injection, SuspensionIntravenous | Lantheus Medical Imaging, Inc. | 11994-011 |