Prescription drug · ANDA
arformoterol tartrate NDC 69097-168
Arformoterol tartrate 15 ug/2mL · Solution · Respiratory (Inhalation) · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-168-53 | 6909701685369097016853 | 30 POUCH in 1 CARTON (69097-168-53) / 1 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-32) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 27, 2022 | |
| 69097-168-64 | 6909701686469097016864 | 12 POUCH in 1 CARTON (69097-168-64) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 22, 2021 | |
| 69097-168-87 | 6909701688769097016887 | 6 POUCH in 1 CARTON (69097-168-87) / 5 VIAL, SINGLE-DOSE in 1 POUCH (69097-168-48) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 22, 2021 |
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)
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207306
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 69097-168_07b162cc-b71c-4750-a10b-2db80625012fSPL ID 07b162cc-b71c-4750-a10b-2db80625012fSPL set ID 70071afd-5323-4019-aca5-5534278829dcRxCUI 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
N469097016853followed by a unit qualifier and the quantityPackage 69097-0168-53. 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.
About NDC 69097-168
- What is NDC 69097-168?
- 69097-168 is the product NDC for arformoterol tartrate, Arformoterol tartrate 15 ug/2mL solution, listed with the FDA by Cipla USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- arformoterol tartrate.
- What is the active ingredient?
- Arformoterol tartrate.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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?
- 10 other product NDCs are listed under this name. See all arformoterol tartrate 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 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 | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Micro Labs Limited | 42571-464 | 42571-0464-73 |
| Arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Fosun Pharma USA Inc. | 72266-259 | 72266-0259-3072266-0259-60 |
| Arformoterol Tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Ingenus Pharmaceuticals, LLC | 50742-395 | 50742-0395-3050742-0395-60 |
| arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Dr. Reddy's Laboratories, Inc. | 43598-777 | 43598-0777-3043598-0777-60 |
| arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-208 | 72603-0208-3072603-0208-60 |
| Arformoterol Tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | American Health Packaging | 60687-770 | 60687-0770-8360687-0770-84 |
| arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Lifestar Pharma LLC | 70756-612 | 70756-0612-6070756-0612-70 |
| Arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Lupin Pharmaceuticals, Inc. | 70748-175 | 70748-0175-3070748-0175-60 |
| Arformoterol Tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 62756-277 | 62756-0277-0262756-0277-03 |
| Arformoterol tartrate | Arformoterol tartrate 15 ug/2mL | SolutionRespiratory (Inhalation) | Alembic Pharmaceuticals Inc. | 62332-633 | 62332-0633-3062332-0633-60 |