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NDC 65862-0942-03 LEVALBUTEROL 1.25 mg/.5mL Details
LEVALBUTEROL 1.25 mg/.5mL
LEVALBUTEROL is a RESPIRATORY (INHALATION) SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is LEVALBUTEROL HYDROCHLORIDE.
MedlinePlus Drug Summary
Levalbuterol is used to prevent or relieve the wheezing, shortness of breath, coughing, and chest tightness caused by lung disease such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Levalbuterol is in a class of medications called beta agonists. It works by relaxing and opening air passages to the lungs to make breathing easier.
Related Packages: 65862-0942-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levalbuterol Oral Inhalation
Product Information
| NDC | 65862-0942 |
|---|---|
| Product ID | 65862-942_08fe55b3-a3cd-d8cf-e063-6394a90a1a95 |
| Associated GPIs | 44201045102560 |
| GCN Sequence Number | 057879 |
| GCN Sequence Number Description | levalbuterol HCl VIAL-NEB 1.25MG/0.5 INHALATION |
| HIC3 | B6W |
| HIC3 Description | BETA-ADRENERGIC AGENTS, INHALED, SHORT ACTING |
| GCN | 23146 |
| HICL Sequence Number | 019858 |
| HICL Sequence Number Description | LEVALBUTEROL HCL |
| Brand/Generic | Generic |
| Proprietary Name | LEVALBUTEROL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LEVALBUTEROL |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 1.25 |
| Active Ingredient Units | mg/.5mL |
| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207628 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0942-03 (65862094203)
| NDC Package Code | 65862-942-03 |
|---|---|
| Billing NDC | 65862094203 |
| Package | 30 POUCH in 1 CARTON (65862-942-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) / .5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2017-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |