Prescription drug · NDA
Omidria (Phenylephrine and ketorolac) NDC 62225-600
Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL · Injection, Solution, Concentrate · Intraocular · Omeros Corporation
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Omidria
- Generic name (nonproprietary)
- phenylephrine and ketorolac
- Active ingredients
- Phenylephrine — 10.16 mg/mLKetorolac — 2.88 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intraocular
- Labeler
- Omeros CorporationNDC labeler code 62225
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205388
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 62225-600_4ef3b158-3042-6a1f-e063-6394a90a807fSPL ID 4ef3b158-3042-6a1f-e063-6394a90a807fSPL set ID 21470688-4e81-4ea5-ac38-f72e10552e7eRxCUI 1540230, 1540235UNII 1WS297W6MV, YZI5105V0L
- Pharmacologic class
- Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug; alpha-1 Adrenergic 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Excerpt only. Read the full label for complete information.
About NDC 62225-600
- What is NDC 62225-600?
- 62225-600 is the product NDC for Omidria, Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL injection, solution, concentrate, listed with the FDA by Omeros Corporation.
- What drug is associated with this NDC?
- Omidria (Phenylephrine and ketorolac).
- What is the active ingredient?
- Phenylephrine, Ketorolac.
- Who is the labeler?
- Omeros Corporation, NDC labeler code 62225. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omidria?
- 1 other product NDC are listed under this name. See all Omidria NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omidria products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omidriaphenylephrine and ketorolac | Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL | Injection, Solution, ConcentrateIntraocular | Rayner Surgical Inc. | 82604-600 | 82604-0600-0082604-0600-0482604-0600-99 |
Other NDCs under NDA 205388
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 |
|---|---|---|---|---|
| Omidriaphenylephrine and ketorolac | Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL | Injection, Solution, ConcentrateIntraocular | Rayner Surgical Inc. | 82604-600 |