GENOSYL
- Product NDC
- 72385-003
- 11-digit product format
- 723850003
- Labeler code
- 72385
- Product ID
- 72385-003_452585c7-a353-8837-e063-6294a90ae85a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitric oxide
- Dosage form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Labeler
- VERO BIOTECH, INC.
- Application
- NDA202860
- Marketing category
- NDA
- Marketing start
- 2025-06-04
- Substance
- NITRIC OXIDE
- Active strength
- .98 mg/L
- Pharmacologic classes
- Vasodilation [PE], Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GENOSYL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITRIC OXIDE | .98 mg/L |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31C4KY9ESH |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72385-003-01 | GENOSYL | 73 L in 1 CARTRIDGE | GAS | 73 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72385-003-01 | 72385000301 | 73 L in 1 CARTRIDGE (72385-003-01) | 73 l | 2025-06-04 | No | No | Current |