Prescription drug · ANDA
Latanoprost NDC 25021-001
Latanoprost 50 ug/mL · Solution/ drops · Ophthalmic · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-001-02 | 25021000102 | 1 BOTTLE in 1 CARTON (25021-001-02) / 2.5 mL in 1 BOTTLEMarketed from Jul 15, 2025 |
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)
- Latanoprost
- Generic name (nonproprietary)
- latanoprost
- Active ingredients
- Latanoprost — 50 ug/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218257
- Marketing start
- Listing expires
- Identifiers
- Product ID 25021-001_8ce78c02-d0b0-4629-b51d-0c674c6e2e43SPL ID 8ce78c02-d0b0-4629-b51d-0c674c6e2e43SPL set ID 7474dc53-e5e5-44f2-9f56-b2cbacdc0c32RxCUI 314072UNII 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
N425021000102followed by a unit qualifier and the quantityPackage 25021-0001-02. 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 .
Indications (excerpt from the label)
Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution 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 ANDA 218257
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 | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-609 |
| latanoprost | Latanoprost 50 ug/mL | Solution/ dropsOphthalmic | GLENMARK PHARMACEUTICALS INC | 68462-944 |