Prescription drug · ANDA
arformoterol tartrate NDC 43598-777
Arformoterol tartrate 15 ug/2mL · Solution · Respiratory (Inhalation) · Dr. Reddy's Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-777-30 | 43598077730 | 30 POUCH in 1 CARTON (43598-777-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-11) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 2, 2024 | |
| 43598-777-60 | 43598077760 | 15 POUCH in 1 CARTON (43598-777-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (43598-777-48) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 2, 2024 |
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)
- arformoterol tartrate
- Generic name (nonproprietary)
- arformoterol tartrate
- Active ingredients
- Arformoterol tartrate — 15 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215032
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 43598-777_a718ab1b-b96b-bed2-24d1-b74c0277daedSPL ID a718ab1b-b96b-bed2-24d1-b74c0277daedSPL set ID d8843369-b0d5-6f0d-1fcd-0c49002df755RxCUI 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
N443598077730followed by a unit qualifier and the quantityPackage 43598-0777-30. 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)
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.