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NDC 76420-0531-01 Albuterol Sulfate 90 ug/1 Details
Albuterol Sulfate 90 ug/1
Albuterol Sulfate is a RESPIRATORY (INHALATION) AEROSOL, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. 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: 76420-0531-01Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Albuterol Oral Inhalation
Product Information
| NDC | 76420-0531 |
|---|---|
| Product ID | 76420-531_f104fd15-0d76-3db4-e053-2995a90a1a88 |
| Associated GPIs | |
| GCN Sequence Number | 028090 |
| GCN Sequence Number Description | albuterol sulfate HFA AER AD 90 MCG INHALATION |
| HIC3 | B6W |
| HIC3 Description | BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING |
| GCN | 22913 |
| HICL Sequence Number | 002073 |
| HICL Sequence Number Description | ALBUTEROL SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Albuterol Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Albuterol Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | AEROSOL, METERED |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 90 |
| Active Ingredient Units | ug/1 |
| Substance Name | ALBUTEROL SULFATE |
| Labeler Name | Asclemed USA, Inc. |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207085 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76420-0531-01 (76420053101)
| NDC Package Code | 76420-531-01 |
|---|---|
| Billing NDC | 76420053101 |
| Package | 200 AEROSOL, METERED in 1 CANISTER (76420-531-01) |
| Marketing Start Date | 2022-12-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |