Prescription drug · ANDA
Latanoprost NDC 61314-547
Latanoprost 50 ug/mL · Solution · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-547-01 | 61314054701 | 1 BOTTLE in 1 CARTON (61314-547-01) / 2.5 mL in 1 BOTTLEMarketed from Jan 7, 2011 | |
| 61314-547-03 | 61314054703 | 3 BOTTLE in 1 CARTON (61314-547-03) / 2.5 mL in 1 BOTTLEMarketed from Jan 7, 2011 |
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
- Route
- Ophthalmic
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091449
- Marketing start
- Listing expires
- Identifiers
- Product ID 61314-547_a4388e84-6b82-4d7d-915b-6997d4b44b36SPL ID a4388e84-6b82-4d7d-915b-6997d4b44b36SPL set ID 1fba56a6-c8dc-4f34-b05d-efdea75d2feaRxCUI 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
N461314054701followed by a unit qualifier and the quantityPackage 61314-0547-01. 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 091449
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 | A-S Medication Solutions | 50090-7062 |
| Latanoprost | Latanoprost 50 ug/mL | SolutionOphthalmic | NuCare Pharmaceuticals, Inc. | 68071-3884 |