Prescription drug · ANDA
Levalbuterol (levalbuterol hydrochloride) NDC 35573-443
Levalbuterol hydrochloride .31 mg/3mL · Solution · Respiratory (Inhalation) · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-443-25 | 35573044325 | 25 POUCH in 1 CARTON (35573-443-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Levalbuterol
- Generic name (nonproprietary)
- levalbuterol hydrochloride
- Active ingredients
- Levalbuterol hydrochloride — .31 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203653
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 35573-443_0639bb69-d41d-4786-af70-797c452fbbfbSPL ID 0639bb69-d41d-4786-af70-797c452fbbfbSPL set ID 737fe40b-798b-4d7f-bec9-7af952018ab5RxCUI 242754, 311286, 349590UNII WDQ1526QJM
- 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
N435573044325followed by a unit qualifier and the quantityPackage 35573-0443-25. 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)
Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203653
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 |
|---|---|---|---|---|
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-800 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-700 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Ritedose Pharmaceuticals, LLC | 76204-900 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Burel Pharmaceuticals, LLC | 35573-444 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Burel Pharmaceuticals, LLC | 35573-445 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-6377 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Amneal Pharmaceuticals of New York LLC | 0115-9930 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Amneal Pharmaceuticals of New York LLC | 0115-9931 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Amneal Pharmaceuticals of New York LLC | 0115-9932 |
| Levalbuterol | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9690 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2271 |
| Levalbuterol | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9691 |
| Levalbuterol | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9692 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Bryant Ranch Prepack | 72162-2081 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2304 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Bryant Ranch Prepack | 72162-2082 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Bryant Ranch Prepack | 72162-2083 |