Prescription drug · NDA AUTHORIZED GENERIC
Levalbuterol tartrate HFA inhalation (Levalbuterol tartrate) NDC 0591-2927
Levalbuterol tartrate 45 ug/1 · Aerosol, Metered · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2927-54 | 0059129275400591292754 | 1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALERMarketed from Oct 3, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 tartrate HFA inhalation
- Generic name (nonproprietary)
- levalbuterol tartrate
- Active ingredients
- Levalbuterol tartrate — 45 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021730
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)
- Identifiers
- Product ID 0591-2927_f9039b6c-2ae3-416b-bc2a-ab6e06e830bfSPL ID f9039b6c-2ae3-416b-bc2a-ab6e06e830bfSPL set ID ac85703a-17a2-4f0b-87f4-78f1756d2f85RxCUI 745791UNII ADS4I3E22M
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400591292754followed by a unit qualifier and the quantityPackage 00591-2927-54. 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 tartrate HFA inhalation aerosol is a beta 2 -adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) 1.1 Bronchospasm Levalbuterol tartrate HFA inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
Excerpt only. Read the full label for complete information.
About NDC 0591-2927
- What is NDC 0591-2927?
- 0591-2927 is the product NDC for Levalbuterol tartrate HFA inhalation, Levalbuterol tartrate 45 ug/1 aerosol, metered, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levalbuterol tartrate HFA inhalation (Levalbuterol tartrate).
- What is the active ingredient?
- Levalbuterol tartrate.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. 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 tartrate HFA inhalation?
- 1 other product NDC are listed under this name. See all Levalbuterol tartrate HFA inhalation NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levalbuterol tartrate HFA inhalation products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levalbuterol tartrate HFA inhalationlevalbuterol tartrate | Levalbuterol tartrate 45 ug/1 | Aerosol, MeteredOral | Proficient Rx LP | 63187-876 | 63187-0876-15 |
Other NDCs under NDA 021730
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 tartrate HFA inhalationlevalbuterol tartrate | Levalbuterol tartrate 45 ug/1 | Aerosol, MeteredOral | Proficient Rx LP | 63187-876 |
| Xopenex HFAlevalbuterol tartrate | Levalbuterol tartrate 45 ug/1 | Aerosol, MeteredOral | Lupin Pharmaceuticals, Inc. | 27437-056 |