Prescription drug · NDA
Perforomist (formoterol fumarate dihydrate) NDC 49502-605
Formoterol fumarate 20 ug/2mL · Solution · Respiratory (Inhalation) · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49502-605-30 | 49502060530 | 30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIALMarketed from Oct 1, 2007 | |
| 49502-605-61 | 49502060561 | 60 POUCH in 1 CARTON (49502-605-61) / 1 VIAL in 1 POUCH (49502-605-95) / 2 mL in 1 VIALMarketed from Oct 1, 2007 |
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)
- Perforomist
- Generic name (nonproprietary)
- formoterol fumarate dihydrate
- Active ingredients
- Formoterol fumarate — 20 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022007
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 49502-605_4607ec7c-6203-4e4b-877f-c6cb03c15590SPL ID 4607ec7c-6203-4e4b-877f-c6cb03c15590SPL set ID fb2fe258-fe2e-47f6-8adf-ca75bf6f90afRxCUI 1246319, 1246321UNII W34SHF8J2K
- 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
N449502060530followed by a unit qualifier and the quantityPackage 49502-0605-30. 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)
PERFOROMIST Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: • PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) • PERFOROMIST Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term,…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022007
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 |
|---|---|---|---|---|
| Formoterol Fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-1631 |