Prescription drug · ANDA
Latanoprostene Bunod Ophthalmic Solution, 0.024% NDC 68083-563
Latanoprostene bunod .24 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-563-01 | 6808305630168083056301 | 1 BOTTLE in 1 CARTON (68083-563-01) / 2.5 mL in 1 BOTTLEMarketed from Apr 29, 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)
- Latanoprostene Bunod Ophthalmic Solution, 0.024%
- Generic name (nonproprietary)
- latanoprostene bunod ophthalmic solution, 0.024%
- Active ingredients
- Latanoprostene bunod — .24 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217387
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-563_fac898b8-b3e7-4db5-a3ff-a3ebcdca84cfSPL ID fac898b8-b3e7-4db5-a3ff-a3ebcdca84cfSPL set ID 1beedfbd-5e2b-4ab1-ab8e-8320e69af1eaRxCUI 1988394UNII I6393O0922
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
N468083056301followed by a unit qualifier and the quantityPackage 68083-0563-01. 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)
Latanoprostene bunod ophthalmic solution, 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprostene bunod ophthalmic solution is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Excerpt only. Read the full label for complete information.
About NDC 68083-563
- What is NDC 68083-563?
- 68083-563 is the product NDC for Latanoprostene Bunod Ophthalmic Solution, 0.024%, Latanoprostene bunod .24 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Latanoprostene Bunod Ophthalmic Solution, 0.024%.
- What is the active ingredient?
- Latanoprostene bunod.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Latanoprostene Bunod Ophthalmic Solution, 0.024%?
- 1 other product NDC are listed under this name. See all Latanoprostene Bunod Ophthalmic Solution, 0.024% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Latanoprostene Bunod Ophthalmic Solution, 0.024% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Latanoprostene Bunod Ophthalmic Solution, 0.024% | Latanoprostene bunod .24 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-564 | 68083-0564-01 |
Other NDCs under ANDA 217387
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 |
|---|---|---|---|---|
| Latanoprostene Bunod Ophthalmic Solution, 0.024% | Latanoprostene bunod .24 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-564 |