Prescription drug · ANDA
Ulspira (Nitric oxide) NDC 82605-008
Nitric oxide .8 mL/100L · Gas · Respiratory (Inhalation) · Airgas Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82605-008-01 | 82605000801 | 2138 L in 1 CYLINDER (82605-008-01)Marketed from Aug 4, 2023 | |
| 82605-008-02 | 82605000802 | 362 L in 1 CYLINDER (82605-008-02)Marketed from Aug 4, 2023 |
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)
- Ulspira
- Generic name (nonproprietary)
- nitric oxide
- Active ingredients
- Nitric oxide — .8 mL/100L
- Dosage form
- Gas
- Route
- Respiratory (Inhalation)
- Labeler
- Airgas Therapeutics, LLCNDC labeler code 82605
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203144
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 82605-008_42659119-4ca6-acf0-e063-6294a90a52eeSPL ID 42659119-4ca6-acf0-e063-6294a90a52eeSPL set ID 2c605fc0-82be-09e0-e063-6394a90a63e9RxCUI 582608, 2702871UNII 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
N482605000801followed by a unit qualifier and the quantityPackage 82605-0008-01. 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 .
About NDC 82605-008
- What is NDC 82605-008?
- 82605-008 is the product NDC for Ulspira (nitric oxide), Nitric oxide .8 mL/100L gas, listed with the FDA by Airgas Therapeutics, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ulspira (Nitric Oxide).
- What is the active ingredient?
- Nitric oxide.
- Who is the labeler?
- Airgas Therapeutics, LLC, NDC labeler code 82605. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ulspira?
- 1 other product NDC are listed under this name. See all Ulspira NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ulspira products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ulspira | Nitric oxide .8 mL/100L | GasRespiratory (Inhalation) | Airgas Therapeutics, LLC | 82605-006 | 82605-0006-0182605-0006-02 |
Other NDCs under ANDA 203144
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 |
|---|---|---|---|---|
| Ulspira | Nitric oxide .8 mL/100L | GasRespiratory (Inhalation) | Airgas Therapeutics, LLC | 82605-006 |