XENOVIEW
- Product NDC
- 80534-6350
- 11-digit product format
- 805346350
- Labeler code
- 80534
- Product ID
- 80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- xenon Xe 129 hyperpolarized
- Dosage form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Polarean, Inc.
- Application
- NDA214375
- Marketing category
- NDA
- Marketing start
- 2022-12-23
- Substance
- HELIUM; NITROGEN; XENON XE-129
- Active strength
- 5651.5; 635; 63.5 L/1; L/1; L/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XENOVIEW
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HELIUM | 5651.5 L/1 |
| NITROGEN | 635 L/1 |
| XENON XE-129 | 63.5 L/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9C7571UDT5, 206GF3GB41, 726Q6M95ZA, N762921K75 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80534-6350-1 | XENOVIEW | 1 in 1 CYLINDER | GAS | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80534-6350 | XENOVIEW (XENON XE 129 HYPERPOLARIZED) GAS [POLAREAN, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250112_70e33fe3-c722-439b-b3db-c2a22f229c8a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80534-6350-1 | 80534635001 | 1 GAS in 1 CYLINDER (80534-6350-1) | 1 gas | 2022-12-23 | 0000-00-00 | No | No | Current |