GENOSYL
- Product NDC
- 72385-002
- 11-digit product format
- 723850002
- Labeler code
- 72385
- Product ID
- 72385-002_45245ace-7b4e-290f-e063-6394a90a8c7e
- 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
- 2022-12-28
- 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 |
|---|
| 72385-002-01 | GENOSYL | 216 L in 1 CARTRIDGE | GAS | 216 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72385-002 | GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241210_8e6b2a92-7915-4709-9076-3a591bf195eb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72385-002-01 | 72385000201 | 216 L in 1 CARTRIDGE (72385-002-01) | 216 l | 2022-12-28 | 0000-00-00 | No | No | Current |