Prescription drug · NDA
ProAir RespiClick (albuterol sulfate) NDC 59310-580
Albuterol sulfate 90 ug/1 · Powder, Metered · Respiratory (Inhalation) · Teva Respiratory, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59310-580-20 | 59310058020 | 1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALERMarketed from May 11, 2015 |
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)
- ProAir RespiClick
- Generic name (nonproprietary)
- albuterol sulfate
- Active ingredients
- Albuterol sulfate — 90 ug/1
- Dosage form
- Powder, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Teva Respiratory, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205636
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 59310-580_f34b3a06-6e6b-4011-b93f-107387f94640SPL ID f34b3a06-6e6b-4011-b93f-107387f94640
- Pharmacologic class
- beta2-Adrenergic Agonist
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
N459310058020followed by a unit qualifier and the quantityPackage 59310-0580-20. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under NDA 205636
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 |
|---|---|---|---|---|
| ProAir Digihaleralbuterol sulfate | Albuterol sulfate 90 ug/1 | InhalantRespiratory (Inhalation) | Teva Respiratory, LLC | 59310-117 |