Prescription drug · ANDA
Arformoterol Tartrate Inhalation Solution NDC 73289-0072
arformoterol tartrate · Arformoterol tartrate 15 ug/2mL · Solution · Respiratory (Inhalation) · Aucta Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73289-0072-3 | 73289007203 | 30 POUCH in 1 CARTON (73289-0072-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 11, 2025 | |
| 73289-0072-4 | 73289007204 | 15 POUCH in 1 CARTON (73289-0072-4) / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 11, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Arformoterol Tartrate Inhalation Solution
- Generic name (nonproprietary)
- arformoterol tartrate
- Active ingredients
- Arformoterol tartrate — 15 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Aucta Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218380
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 73289-0072_2de3ae20-a1ec-6be3-e063-6294a90af05aSPL ID 2de3ae20-a1ec-6be3-e063-6294a90af05aSPL set ID 8c0d81db-fbf5-405f-9311-d3d78992d9a3RxCUI 668956UNII 5P8VJ2I235
- 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
N473289007203followed by a unit qualifier and the quantityPackage 73289-0072-03. 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)
Arformoterol Tartrate 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: Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD Arformoterol Tartrate Inhalation Solution is indicated for th…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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