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NDC 59651-0183-25 ALBUTEROL SULFATE 0.63 mg/3mL Details
ALBUTEROL SULFATE 0.63 mg/3mL
ALBUTEROL SULFATE is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ALBUTEROL SULFATE.
MedlinePlus Drug Summary
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 years of age and older. Albuterol solution for oral inhalation is used in adults and children 2 years of age and older. Albuterol is in a class of medications called bronchodilators. It works by relaxing and opening air passages to the lungs to make breathing easier.
Related Packages: 59651-0183-25Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Albuterol Oral Inhalation
Product Information
| NDC | 59651-0183 |
|---|---|
| Product ID | 59651-183_08ec99ba-a06f-89c0-e063-6294a90a306e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ALBUTEROL SULFATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ALBUTEROL SULFATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 0.63 |
| Active Ingredient Units | mg/3mL |
| Substance Name | ALBUTEROL SULFATE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211888 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59651-0183-25 (59651018325)
| NDC Package Code | 59651-183-25 |
|---|---|
| Billing NDC | 59651018325 |
| Package | 25 POUCH in 1 CARTON (59651-183-25) / 5 VIAL in 1 POUCH (59651-183-05) / 3 mL in 1 VIAL |
| Marketing Start Date | 2020-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |