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NDC 63629-8813-01 Formoterol fumarate 20 ug/2mL Details
Formoterol fumarate 20 ug/2mL
Formoterol fumarate is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is FORMOTEROL FUMARATE.
MedlinePlus Drug Summary
Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 63629-8813-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Formoterol Oral Inhalation
Product Information
| NDC | 63629-8813 |
|---|---|
| Product ID | 63629-8813_37f67ff0-5292-47b4-849e-25cf51d1d61b |
| Associated GPIs | 44201027102520 |
| GCN Sequence Number | 063016 |
| GCN Sequence Number Description | formoterol fumarate VIAL-NEB 20 MCG/2ML INHALATION |
| HIC3 | B6Y |
| HIC3 Description | BETA-ADRENERGIC AGENTS, ORALLY INHALED,LONG ACTING |
| GCN | 98776 |
| HICL Sequence Number | 010747 |
| HICL Sequence Number Description | FORMOTEROL FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Formoterol fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Formoterol fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | ug/2mL |
| Substance Name | FORMOTEROL FUMARATE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091141 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-8813-01 (63629881301)
| NDC Package Code | 63629-8813-1 |
|---|---|
| Billing NDC | 63629881301 |
| Package | 30 POUCH in 1 CARTON (63629-8813-1) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL |
| Marketing Start Date | 2021-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |