Prescription drug · ANDA
latanoprost NDC 68083-609
Latanoprost 50 ug/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-609-01 | 68083060901 | 1 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLEMarketed from Nov 26, 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)
- latanoprost
- Generic name (nonproprietary)
- latanoprost
- Active ingredients
- Latanoprost — 50 ug/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218257
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-609_c63757a2-c757-4098-a29d-7a94104d050fSPL ID c63757a2-c757-4098-a29d-7a94104d050fSPL set ID 113abcc6-6e5c-4a57-ad6a-d69508ee990eRxCUI 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
N468083060901followed by a unit qualifier and the quantityPackage 68083-0609-01. 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)
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 | Sagent Pharmaceuticals | 25021-001 |
| latanoprost | Latanoprost 50 ug/mL | Solution/ dropsOphthalmic | GLENMARK PHARMACEUTICALS INC | 68462-944 |