Prescription drug · NDA
Xenoview (Xenon xe 129 hyperpolarized) NDC 80534-6350
Xenon xe-129 63.5 L/1 + 2 more ingredients · Gas · Respiratory (Inhalation) · Polarean, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80534-6350-1 | 80534635001 | 1 GAS in 1 CYLINDER (80534-6350-1)Marketed from Dec 23, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Xenoview
- Generic name (nonproprietary)
- xenon xe 129 hyperpolarized
- Active ingredients
- Xenon xe-129 — 63.5 L/1Nitrogen — 635 L/1Helium — 5651.5 L/1
- Dosage form
- Gas
- Route
- Respiratory (Inhalation)
- Labeler
- Polarean, Inc.NDC labeler code 80534
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214375
- Marketing start
- Listing expires
- Identifiers
- Product ID 80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5SPL ID 2d171c31-4d16-4bc1-9b90-b69631feadd5SPL set ID 70e33fe3-c722-439b-b3db-c2a22f229c8aUNII 9C7571UDT5, 206GF3GB41, 726Q6M95ZA, N762921K75
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.
- NDC on a medical claim
N480534635001followed by a unit qualifier and the quantityPackage 80534-6350-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
XENOVIEW ® , prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 80534-6350
- What is NDC 80534-6350?
- 80534-6350 is the product NDC for Xenoview (xenon xe 129 hyperpolarized), Xenon xe-129 63.5 L/1 + 2 more ingredients gas, listed with the FDA by Polarean, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xenoview (Xenon Xe 129 hyperpolarized).
- What is the active ingredient?
- Xenon xe-129, Nitrogen, Helium.
- Who is the labeler?
- Polarean, Inc., NDC labeler code 80534. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xenoview?
- 4 other product NDCs are listed under this name. See all Xenoview NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xenoview products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/300mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0300 | 80534-0300-01 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/500mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0500 | 80534-0500-01 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/750mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0750 | 80534-0750-01 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/L | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-1000 | 80534-1000-0180534-1000-02 |
Other NDCs under NDA 214375
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 |
|---|---|---|---|---|
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/300mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0300 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/500mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0500 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/750mL | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-0750 |
| Xenoviewxenon xe 129 hyperpolarized | Xenon xe-129, Hyperpolarized 75 mL/L | GasRespiratory (Inhalation) | Polarean, Inc. | 80534-1000 |