Prescription drug · NDA
Xdemvy (Lotilaner ophthalmic solution) NDC 81942-125
Lotilaner 2.5 mg/mL · Solution/ drops · Ophthalmic · Tarsus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81942-125-01 | 81942012501 | 1 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPERMarketed from Aug 14, 2023 | |
| 81942-125-99 | 81942012599 | 1 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
N481942012501followed by a unit qualifier and the quantityPackage 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.
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.