Prescription drug · NDA
Xalatan (latanoprost) NDC 58151-419
Latanoprost 50 ug/mL · Solution/ drops · Ophthalmic · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-419-35 | 58151041935 | 1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Oct 22, 2024 |
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)
- Xalatan
- Generic name (nonproprietary)
- latanoprost
- Active ingredients
- Latanoprost — 50 ug/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020597
- Marketing start
- Listing expires
- Identifiers
- Product ID 58151-419_45489b8b-2aab-4336-8552-1524493289f9SPL ID 45489b8b-2aab-4336-8552-1524493289f9SPL set ID a98595b3-9f47-48e0-b18d-550a2095f264RxCUI 314072, 542527UNII 6Z5B6HVF6O
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
N458151041935followed by a unit qualifier and the quantityPackage 58151-0419-35. 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)
XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. XALATAN is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020597
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Latanoprost | Latanoprost 50 ug/mL | SolutionOphthalmic | Mylan Pharmaceuticals Inc. | 59762-0333 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.