Levalbuterol NDC 0378-9692

Product information

Brand name (proprietary)

Levalbuterol

Generic name (nonproprietary)

levalbuterol

Active ingredients

Levalbuterol hydrochloride — 1.25 mg/3mL

Dosage form

Solution

Route

Respiratory (Inhalation)

Labeler

Mylan Pharmaceuticals Inc.NDC labeler code 0378

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 203653

Marketing start

Sep 10, 2018

Listing expires

Dec 31, 2027

Other FDA classes

Adrenergic beta2-Agonists (Mechanism)

Identifiers

Product ID 0378-9692_2f82efe7-5a39-44e6-a7c0-840a60c6246fSPL ID 2f82efe7-5a39-44e6-a7c0-840a60c6246fSPL set ID 5b4fa89e-aa46-4504-a275-246f3b4df1dfRxCUI 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

N400378969252 followed by a unit qualifier and the quantity Copy

Package 00378-9692-52. 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

About NDC 0378-9692

What is NDC 0378-9692?

0378-9692 is the product NDC for Levalbuterol, Levalbuterol hydrochloride 1.25 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

All 30 Levalbuterol NDCs

Other NDCs under ANDA 203653

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