Prescription drug · NDA
Omlonti (Omidenepag isopropyl) NDC 84826-002
Omidenepag isopropyl .02 mg/mL · Solution/ drops · Ophthalmic · Ocuvex Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84826-002-01 | 84826000201 | 1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Apr 28, 2025 | |
| 84826-002-03 | 84826000203 | 3 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Apr 28, 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)
- Omlonti
- Generic name (nonproprietary)
- omidenepag isopropyl
- Active ingredients
- Omidenepag isopropyl — .02 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Ocuvex Therapeutics, Inc.NDC labeler code 84826
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215092
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandin E2 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 84826-002_33504c5f-664b-4f6b-e063-6294a90a2aeaSPL ID 33504c5f-664b-4f6b-e063-6294a90a2aeaSPL set ID 4258e437-7e92-4b09-baf1-01cb158cfc05RxCUI 2612702, 2612704UNII G0G0H52U6K
- Pharmacologic class
- Prostaglandin E2 Receptor Agonist
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
N484826000201followed by a unit qualifier and the quantityPackage 84826-0002-01. 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)
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 84826-002
- What is NDC 84826-002?
- 84826-002 is the product NDC for Omlonti (omidenepag isopropyl), Omidenepag isopropyl .02 mg/mL solution/ drops, listed with the FDA by Ocuvex Therapeutics, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omlonti (Omidenepag isopropyl).
- What is the active ingredient?
- Omidenepag isopropyl.
- Who is the labeler?
- Ocuvex Therapeutics, Inc., NDC labeler code 84826. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omlonti?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.