Prescription drug · ANDA
Formoterol fumarate NDC 63629-8813
Formoterol fumarate 20 ug/2mL · Solution · Respiratory (Inhalation) · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8813-1 | 6362988130163629881301 | 30 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIALMarketed from Sep 10, 2021 |
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)
- Formoterol fumarate
- Generic name (nonproprietary)
- formoterol fumarate
- Active ingredients
- Formoterol fumarate — 20 ug/2mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091141
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61bSPL ID 37f67ff0-5292-47b4-849e-25cf51d1d61bSPL set ID 9786f3e2-4265-4246-9999-f73cd6b33fc8RxCUI 1246319UNII W34SHF8J2K
- 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
N463629881301followed by a unit qualifier and the quantityPackage 63629-8813-01. 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)
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 63629-8813
- What is NDC 63629-8813?
- 63629-8813 is the product NDC for Formoterol fumarate, Formoterol fumarate 20 ug/2mL solution, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Formoterol fumarate.
- What is the active ingredient?
- Formoterol fumarate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 fumarateformoterol fumarate dihydrate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Lifestar Pharma LLC | 70756-608 | 70756-0608-6070756-0608-70 |
| 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 |
Other NDCs under ANDA 091141
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 fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-4061 |
| Formoterol fumarate | Formoterol fumarate 20 ug/2mL | SolutionRespiratory (Inhalation) | Bryant Ranch Prepack | 63629-8814 |