What is NDC 99207-850?

99207-850 is the product NDC for Luzu (luliconazole), Luliconazole 10 mg/g cream, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bausch Health US, LLC, NDC labeler code 99207. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Luzu?

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.

Luzu NDC 99207-850 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)99207-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width99207-0850Add 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
99207-850-02	99207085002	12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBEMarketed from Nov 14, 2013 · Sample package
99207-850-60	99207085060	1 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBEMarketed from Nov 14, 2013

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): Luzu
Generic name (nonproprietary): luliconazole
Active ingredients: Luliconazole — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Bausch Health US, LLCNDC labeler code 99207
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204153
Marketing start: Nov 14, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)
Identifiers: Product ID 99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387SPL ID f18334bd-5ed1-43b2-87ba-80b803b54387SPL set ID a7016010-ce43-4c09-8d21-aeb697ffed31RxCUI 1482684, 1482689UNII RE91AN4S8G
Pharmacologic class: Azole Antifungal

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N499207085002 followed by a unit qualifier and the quantity

Package 99207-0850-02. 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 1, 2020.

Indications (excerpt from the label)

LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 99207-850

What is NDC 99207-850?: 99207-850 is the product NDC for Luzu (luliconazole), Luliconazole 10 mg/g cream, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Luzu (Luliconazole).
What is the active ingredient?: Luliconazole.
Who is the labeler?: Bausch Health US, LLC, NDC labeler code 99207. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Luzu?: 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 204153

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

FDA NDC Directory listings under NDA 204153
Product	Strength	Form · route	Labeler	Product NDC
Luliconazole	Luliconazole 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-850

Luzu (Luliconazole) NDC 99207-850