XENOVIEW
- Product NDC
- 80534-0500
- 11-digit product format
- 805340500
- Labeler code
- 80534
- Product ID
- 80534-0500_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
- XENON XE-129, HYPERPOLARIZED
- Active strength
- 75 mL/500mL
- Pharmacologic classes
- Hyperpolarized Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
- 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 |
|---|
| XENON XE-129, HYPERPOLARIZED | 75 mL/500mL |
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 |
|---|
| 80534-0500-1 | XENOVIEW | 500 mL in 1 BAG | GAS | 500 | | 5 |
| 80534-0500-1 | XENOVIEW | 50 in 1 CARTON | GAS | 50 | | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80534-0500-1 | 80534050001 | 50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG | 50 bag | 2025-05-30 | No | No | Historical |