Prescription drug · ANDA

Levalbuterol (levalbuterol hydrochloride) NDC 0115-9931

Levalbuterol hydrochloride .63 mg/3mL · Solution · Respiratory (Inhalation) · Amneal Pharmaceuticals of New York LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0115-9931Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00115-9931Add 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 NDC11-digit (billing)PackageCopy
0115-9931-78001159931781 POUCH in 1 CARTON (0115-9931-78) / 25 AMPULE in 1 POUCH (0115-9931-76) / 3 mL in 1 AMPULEMarketed from Feb 17, 2017

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
Generic name (nonproprietary)
levalbuterol hydrochloride
Active ingredients
Levalbuterol hydrochloride — .63 mg/3mL
Dosage form
Solution
Route
Respiratory (Inhalation)
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 0115-9931_be1c7c11-31c8-4e84-bf0a-e395f0a21485SPL ID be1c7c11-31c8-4e84-bf0a-e395f0a21485SPL set ID e5c8368a-49f9-45cf-9d42-a871f005edb9RxCUI 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

N400115993178 followed by a unit qualifier and the quantity

Package 00115-9931-78. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203653

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

FDA NDC Directory listings under ANDA 203653
ProductStrengthForm · routeLabelerProduct NDC
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-800
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .31 mg/3mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-700
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride 1.25 mg/3mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-900
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .31 mg/3mLSolutionRespiratory (Inhalation)Burel Pharmaceuticals, LLC35573-443
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Burel Pharmaceuticals, LLC35573-444
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride 1.25 mg/3mLSolutionRespiratory (Inhalation)Burel Pharmaceuticals, LLC35573-445
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)A-S Medication Solutions50090-6377
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .31 mg/3mLSolutionRespiratory (Inhalation)Amneal Pharmaceuticals of New York LLC0115-9930
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride 1.25 mg/3mLSolutionRespiratory (Inhalation)Amneal Pharmaceuticals of New York LLC0115-9932
LevalbuterolLevalbuterol hydrochloride .31 mg/3mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-9690
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Redpharm Drug67296-2271
LevalbuterolLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-9691
LevalbuterolLevalbuterol hydrochloride 1.25 mg/3mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-9692
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .31 mg/3mLSolutionRespiratory (Inhalation)Bryant Ranch Prepack72162-2081
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Redpharm Drug67296-2304
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride .63 mg/3mLSolutionRespiratory (Inhalation)Bryant Ranch Prepack72162-2082
Levalbuterollevalbuterol hydrochlorideLevalbuterol hydrochloride 1.25 mg/3mLSolutionRespiratory (Inhalation)Bryant Ranch Prepack72162-2083

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Levalbuterol (levalbuterol hydrochloride) NDC 0115-9931 | Med-Code