Prescription drug · NDA
Genosyl (Nitric oxide) NDC 72385-001
Nitric oxide .98 mg/L · Gas · Respiratory (Inhalation) · VERO BIOTECH, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72385-001-01 | 72385000101 | 216 L in 1 CARTRIDGE (72385-001-01)Marketed from Dec 20, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Genosyl
- Generic name (nonproprietary)
- nitric oxide
- Active ingredients
- Nitric oxide — .98 mg/L
- Dosage form
- Gas
- Route
- Respiratory (Inhalation)
- Labeler
- VERO BIOTECH, INC.NDC labeler code 72385
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202860
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 72385-001_45b32a3c-e568-50bd-e063-6294a90ae9a6SPL ID 45b32a3c-e568-50bd-e063-6294a90ae9a6SPL set ID c9560c54-9e28-4039-a4e5-5000c41c6c85UNII 31C4KY9ESH
- Pharmacologic class
- Vasodilator
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
N472385000101followed by a unit qualifier and the quantityPackage 72385-0001-01. 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)
GENOSYL ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. GENOSYL ® is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents (…
Excerpt only. Read the full label for complete information.
About NDC 72385-001
- What is NDC 72385-001?
- 72385-001 is the product NDC for Genosyl (nitric oxide), Nitric oxide .98 mg/L gas, listed with the FDA by VERO BIOTECH, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Genosyl (Nitric oxide).
- What is the active ingredient?
- Nitric oxide.
- Who is the labeler?
- VERO BIOTECH, INC., NDC labeler code 72385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Genosyl?
- 2 other product NDCs are listed under this name. See all Genosyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Genosyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Genosylnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | VERO BIOTECH, INC. | 72385-003 | 72385-0003-01 |
| Genosylnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | VERO BIOTECH, INC. | 72385-002 | 72385-0002-01 |
Other NDCs under NDA 202860
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 |
|---|---|---|---|---|
| Genosylnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | VERO BIOTECH, INC. | 72385-003 |
| Genosylnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | VERO BIOTECH, INC. | 72385-002 |