Prescription drug · NDA AUTHORIZED GENERIC
Formoterol Fumarate (formoterol fumarate dihydrate) NDC 0378-1631
Formoterol fumarate 20 ug/2mL · Solution · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-1631-91 | 00378163191 | 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIALMarketed from Jun 22, 2021 | |
| 0378-1631-93 | 00378163193 | 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIALMarketed from Jun 22, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Formoterol Fumarate
- Generic name (nonproprietary)
- formoterol fumarate dihydrate
- Active ingredients
- Formoterol fumarate — 20 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022007
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 0378-1631_db19667d-88cd-47ab-adb5-894959822801SPL ID db19667d-88cd-47ab-adb5-894959822801SPL set ID 6c1a6c53-af85-4220-9ce3-2373e0928f7fRxCUI 1246319UNII 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
N400378163191followed by a unit qualifier and the quantityPackage 00378-1631-91. 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)
Formoterol fumarate 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: • Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) • Formoterol fumarate inhalation solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD Formoterol fumarate inhalation solution is indicated for the …
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 |
|---|---|---|---|---|
| Perforomistformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Viatris Specialty LLC | 49502-605 |