What is NDC 47335-753?

47335-753 is the product NDC for Levalbuterol Inhalation Solution, Levalbuterol hydrochloride 1.25 mg/3mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 Inhalation Solution?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levalbuterol Inhalation Solution NDC 47335-753

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-753Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0753Add 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
47335-753-01	47335075301	5 POUCH in 1 CARTON (47335-753-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 1, 2020
47335-753-49	47335075349	2 POUCH in 1 CARTON (47335-753-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2018
47335-753-52	47335075352	6 POUCH in 1 CARTON (47335-753-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2018

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 Inhalation Solution
Generic name (nonproprietary): levalbuterol inhalation solution
Active ingredients: Levalbuterol hydrochloride — 1.25 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207820
Marketing start: Dec 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 47335-753_f264b091-1414-4e44-abae-d0b787c94397SPL ID f264b091-1414-4e44-abae-d0b787c94397SPL set ID 85a59e0c-ff09-49a6-b7b8-616e033107b4RxCUI 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

N447335075301 followed by a unit qualifier and the quantity

Package 47335-0753-01. 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 Apr 23, 2020.

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 47335-753

What is NDC 47335-753?: 47335-753 is the product NDC for Levalbuterol Inhalation Solution, Levalbuterol hydrochloride 1.25 mg/3mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levalbuterol Inhalation Solution.
What is the active ingredient?: Levalbuterol hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 Inhalation Solution?: 2 other product NDCs are listed under this name. See all Levalbuterol Inhalation Solution 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 Inhalation Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levalbuterol Inhalation Solution	Levalbuterol hydrochloride .63 mg/3mL	SolutionRespiratory (Inhalation)	Sun Pharmaceutical Industries, Inc.	47335-746	47335-0746-0147335-0746-4947335-0746-52
Levalbuterol Inhalation Solution	Levalbuterol hydrochloride .31 mg/3mL	SolutionRespiratory (Inhalation)	Sun Pharmaceutical Industries, Inc.	47335-743	47335-0743-0147335-0743-4947335-0743-52

Other NDCs under ANDA 207820

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

FDA NDC Directory listings under ANDA 207820
Product	Strength	Form · route	Labeler	Product NDC
Levalbuterol Inhalation Solution	Levalbuterol hydrochloride .63 mg/3mL	SolutionRespiratory (Inhalation)	Sun Pharmaceutical Industries, Inc.	47335-746
Levalbuterol Inhalation Solution	Levalbuterol hydrochloride .31 mg/3mL	SolutionRespiratory (Inhalation)	Sun Pharmaceutical Industries, Inc.	47335-743