NDC codes

FDA NDC Directory
Product NDC (as listed)81942-125Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81942-0125Add 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
81942-125-01819420125011 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPERMarketed from Aug 14, 2023
81942-125-99819420125991 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPERMarketed from Aug 14, 2023

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)
Xdemvy
Generic name (nonproprietary)
lotilaner ophthalmic solution
Active ingredients
Lotilaner — 2.5 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Tarsus Pharmaceuticals, Inc.NDC labeler code 81942
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217603
Marketing start
Listing expires
Identifiers
Product ID 81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3SPL ID 1f574fcb-3810-2e5c-e063-6394a90aafd3SPL set ID ccd9e37c-654e-4e84-8c85-6523457df979RxCUI 2644507, 2644512UNII HEH4938D7K
Pharmacologic class
Ectoparasiticide

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

NDC on a medical claim

N481942012501 followed by a unit qualifier and the quantity

Package 81942-0125-01. 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 .

Indications (excerpt from the label)

XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81942-125

What is NDC 81942-125?
81942-125 is the product NDC for Xdemvy (lotilaner ophthalmic solution), Lotilaner 2.5 mg/mL solution/ drops, listed with the FDA by Tarsus Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Xdemvy (Lotilaner ophthalmic solution).
What is the active ingredient?
Lotilaner.
Who is the labeler?
Tarsus Pharmaceuticals, Inc., NDC labeler code 81942. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xdemvy?
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.

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