Prescription drug · ANDA
Arformoterol Tartrate Inhalation Solution NDC 76204-026
Arformoterol tartrate 15 ug/2mL · Solution · Respiratory (Inhalation) · Ritedose Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76204-026-01 | 7620400260176204002601 | 30 POUCH in 1 CARTON (76204-026-01) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Feb 27, 2023 | |
| 76204-026-02 | 7620400260276204002602 | 60 POUCH in 1 CARTON (76204-026-02) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Feb 27, 2023 | |
| 76204-026-55 | 7620400265576204002655 | 12 POUCH in 1 CARTON (76204-026-55) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Feb 27, 2023 |
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 Inhalation Solution
- Generic name (nonproprietary)
- arformoterol tartrate inhalation solution
- Active ingredients
- Arformoterol tartrate — 15 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Ritedose Pharmaceuticals, LLCNDC labeler code 76204
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214736
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 76204-026_459f97a4-5026-29d1-e063-6294a90a1a9aSPL ID 459f97a4-5026-29d1-e063-6294a90a1a9aSPL set ID ef524b4c-68d7-c464-e053-2a95a90a7f96RxCUI 668956UNII 5P8VJ2I235UPC 0376204026024, 0376204026017
- 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
N476204002601followed by a unit qualifier and the quantityPackage 76204-0026-01. 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)
1. INDICATIONS AND USAGE 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 inidcated 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 i…
Excerpt only. Read the full label for complete information.
About NDC 76204-026
- What is NDC 76204-026?
- 76204-026 is the product NDC for Arformoterol Tartrate Inhalation Solution, Arformoterol tartrate 15 ug/2mL solution, listed with the FDA by Ritedose Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arformoterol Tartrate Inhalation Solution.
- What is the active ingredient?
- Arformoterol tartrate.
- Who is the labeler?
- Ritedose Pharmaceuticals, LLC, NDC labeler code 76204. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arformoterol Tartrate Inhalation Solution?
- 1 other product NDC are listed under this name. See all Arformoterol Tartrate Inhalation Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arformoterol Tartrate Inhalation Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Arformoterol Tartrate Inhalation Solutionarformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Aucta Pharmaceuticals, Inc. | 73289-0072 | 73289-0072-0373289-0072-04 |