Prescription drug · ANDA
Formoterol fumarate (Formoterol fumarate dihydrate) NDC 70756-608
Formoterol fumarate 20 ug/2mL · Solution · Respiratory (Inhalation) · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-608-60 | 7075606086070756060860 | 60 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIALMarketed from Mar 22, 2023 | |
| 70756-608-70 | 7075606087070756060870 | 30 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIALMarketed from Mar 22, 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)
- Formoterol fumarate
- Generic name (nonproprietary)
- formoterol fumarate dihydrate
- Active ingredients
- Formoterol fumarate — 20 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Lifestar Pharma LLCNDC labeler code 70756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215883
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 70756-608_7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2aSPL ID 7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2aSPL set ID 35538d89-a984-4335-acdf-85a893f51eeeRxCUI 1246319UNII W34SHF8J2KUPC 0370756608127
- 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
N470756060860followed by a unit qualifier and the quantityPackage 70756-0608-60. 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 long-t…
Excerpt only. Read the full label for complete information.
About NDC 70756-608
- What is NDC 70756-608?
- 70756-608 is the product NDC for Formoterol fumarate (formoterol fumarate dihydrate), Formoterol fumarate 20 ug/2mL solution, listed with the FDA by Lifestar Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Formoterol fumarate (Formoterol fumarate dihydrate).
- What is the active ingredient?
- Formoterol fumarate.
- Who is the labeler?
- Lifestar Pharma LLC, NDC labeler code 70756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Formoterol fumarate?
- 11 other product NDCs are listed under this name. See all Formoterol fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Formoterol fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Formoterol fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Devatis, Inc. | 73043-051 | 73043-0051-9373043-0051-96 |
| Formoterol Fumarate | Formoterol fumarate .02 mg/2mL | SolutionRespiratory (Inhalation) | Ingenus Pharmaceuticals, LLC | 50742-394 | 50742-0394-3050742-0394-60 |
| Formoterol Fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Dr. Reddy's Laboratories Inc. | 43598-778 | 43598-0778-3043598-0778-60 |
| Formoterol fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Micro Labs Limited | 42571-463 | 42571-0463-6242571-0463-73 |
| Formoterol fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-620 | 72603-0620-3072603-0620-60 |
| formoterol fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Lupin Pharmaceuticals, Inc. | 70748-261 | 70748-0261-3070748-0261-60 |
| Formoterol Fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Alembic Pharmaceuticals Inc. | 62332-655 | 62332-0655-3062332-0655-60 |
| Formoterol fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-4061 | 00093-4061-0600093-4061-30 |
| Formoterol Fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-1631 | 00378-1631-9100378-1631-93 |
| Formoterol fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8813 | 63629-8813-01 |
Other NDCs under ANDA 215883
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 |
|---|---|---|---|---|
| Formoterol fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | NorthStar RxLLC | 72603-620 |