What is NDC 65862-945?

65862-945 is the product NDC for Levalbuterol, Levalbuterol hydrochloride 1.25 mg/3mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levalbuterol NDC 65862-945 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-945Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0945Add 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
65862-945-25	65862094525	5 POUCH in 1 CARTON (65862-945-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-945-05) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 30, 2016

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 — 1.25 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207625
Marketing start: Dec 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 65862-945_29ed39d7-180a-93e4-e063-6294a90a73a9SPL ID 29ed39d7-180a-93e4-e063-6294a90a73a9SPL set ID 5f1c4f22-d420-495c-8f64-33532638215fRxCUI 242754, 311286, 349590UNII WDQ1526QJMUPC 0365862943057, 0365862943255, 0365862944252, 0365862945051, 0365862944054, 0365862945259
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

N465862094525 followed by a unit qualifier and the quantity

Package 65862-0945-25. 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 Dec 24, 2024. This label includes a boxed warning.

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 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)

About NDC 65862-945

What is NDC 65862-945?: 65862-945 is the product NDC for Levalbuterol, Levalbuterol hydrochloride 1.25 mg/3mL solution, listed with the FDA by Aurobindo Pharma Limited. 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Levalbuterol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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
Levalbuterollevalbuterol hydrochloride	Levalbuterol hydrochloride .63 mg/3mL	SolutionRespiratory (Inhalation)	Redpharm Drug	67296-2304	67296-2304-02
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 .31 mg/3mL	SolutionRespiratory (Inhalation)	Aurobindo Pharma Limited	65862-943	65862-0943-25

All 30 Levalbuterol NDCs

Other NDCs under ANDA 207625

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

FDA NDC Directory listings under ANDA 207625
Product	Strength	Form · route	Labeler	Product NDC
Levalbuterol	Levalbuterol hydrochloride .31 mg/3mL	SolutionRespiratory (Inhalation)	Aurobindo Pharma Limited	65862-943
Levalbuterol	Levalbuterol hydrochloride .63 mg/3mL	SolutionRespiratory (Inhalation)	Aurobindo Pharma Limited	65862-944
Levalbuterol	Levalbuterol hydrochloride .31 mg/3mL	SolutionRespiratory (Inhalation)	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	81894-101
Levalbuterol	Levalbuterol hydrochloride .63 mg/3mL	SolutionRespiratory (Inhalation)	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	81894-102
Levalbuterol	Levalbuterol hydrochloride 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	81894-103