Prescription drug · ANDA
Levalbuterol NDC 63187-953
Levalbuterol hydrochloride .63 mg/3mL · Solution · Respiratory (Inhalation) · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-953-24 | 63187095324 | 24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 1, 2018 |
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
- Active ingredients
- Levalbuterol hydrochloride — .63 mg/3mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090297
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 63187-953_efb4df4c-19c2-4c42-bf10-d1613186db7bSPL ID efb4df4c-19c2-4c42-bf10-d1613186db7bSPL set ID 97699821-81f8-4623-8504-e479c0f4b183RxCUI 311286UNII 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
N463187095324followed by a unit qualifier and the quantityPackage 63187-0953-24. 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 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.
About NDC 63187-953
- What is NDC 63187-953?
- 63187-953 is the product NDC for Levalbuterol, Levalbuterol hydrochloride .63 mg/3mL solution, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levalbuterol.
- What is the active ingredient?
- Levalbuterol hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levalbuterol?
- 29 other product NDCs are listed under this name. See all Levalbuterol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levalbuterol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Redpharm Drug | 67296-2304 | 67296-2304-02 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Burel Pharmaceuticals, LLC | 35573-443 | 35573-0443-25 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Burel Pharmaceuticals, LLC | 35573-444 | 35573-0444-25 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Burel Pharmaceuticals, LLC | 35573-445 | 35573-0445-25 |
| Levalbuterollevalbuterol hydrochloride | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | A-S Medication Solutions | 50090-6377 | 50090-6377-00 |
| Levalbuterol | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9692 | 00378-9692-52 |
| Levalbuterol | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9690 | 00378-9690-52 |
| Levalbuterol | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-9691 | 00378-9691-52 |
| Levalbuterol | Levalbuterol hydrochloride 1.25 mg/.5mL | Solution, ConcentrateRespiratory (Inhalation) | Aurobindo Pharma Limited | 65862-942 | 65862-0942-03 |
| Levalbuterol | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Aurobindo Pharma Limited | 65862-945 | 65862-0945-25 |
Other NDCs under ANDA 090297
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 |
|---|---|---|---|---|
| Levalbuterol | Levalbuterol hydrochloride .31 mg/3mL | SolutionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-4145 |
| Levalbuterol | Levalbuterol hydrochloride .63 mg/3mL | SolutionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-4146 |
| Levalbuterol | Levalbuterol hydrochloride 1.25 mg/3mL | SolutionRespiratory (Inhalation) | Teva Pharmaceuticals USA, Inc. | 0093-4148 |