What is NDC 27437-056?

27437-056 is the product NDC for Xopenex HFA (levalbuterol tartrate), Levalbuterol tartrate 45 ug/1 aerosol, metered, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Xopenex HFA (Levalbuterol tartrate).

Lupin Pharmaceuticals, Inc., NDC labeler code 27437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xopenex HFA?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xopenex HFA NDC 27437-056 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)27437-056Labeler and product segments. Claims need a package NDC.

Product NDC at billing width27437-0056Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
27437-056-01	27437005601	1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALERMarketed from Nov 10, 2023

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): Xopenex HFA
Generic name (nonproprietary): levalbuterol tartrate
Active ingredients: Levalbuterol tartrate — 45 ug/1
Dosage form: Aerosol, Metered
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 27437
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021730
Marketing start: Nov 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 27437-056_905559df-c984-469d-b6b1-a38fdc320471SPL ID 905559df-c984-469d-b6b1-a38fdc320471SPL set ID 70a35706-d7a8-4a48-98c6-1cab1c42fe8dRxCUI 745791, 746466UNII 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

N427437005601 followed by a unit qualifier and the quantity

Package 27437-0056-01. 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 Jun 2, 2025.

Indications (excerpt from the label)

XOPENEX HFA 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 XOPENEX HFA 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.

Full label on DailyMed (opens in a new tab)

About NDC 27437-056

What is NDC 27437-056?: 27437-056 is the product NDC for Xopenex HFA (levalbuterol tartrate), Levalbuterol tartrate 45 ug/1 aerosol, metered, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xopenex HFA (Levalbuterol tartrate).
What is the active ingredient?: Levalbuterol tartrate.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 27437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xopenex HFA?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 021730

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021730
Product	Strength	Form · route	Labeler	Product NDC
Levalbuterol tartrate HFA inhalationlevalbuterol tartrate	Levalbuterol tartrate 45 ug/1	Aerosol, MeteredOral	Actavis Pharma, Inc.	0591-2927
Levalbuterol tartrate HFA inhalationlevalbuterol tartrate	Levalbuterol tartrate 45 ug/1	Aerosol, MeteredOral	Proficient Rx LP	63187-876

Xopenex HFA (Levalbuterol tartrate) NDC 27437-056