Prescription drug · NDA
Omidria (Phenylephrine and ketorolac) NDC 82604-600
Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL · Injection, Solution, Concentrate · Intraocular · Rayner Surgical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82604-600-00 | 82604060000 | 1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIALMarketed from Jul 1, 2023 | |
| 82604-600-04 | 82604060004 | 4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIALMarketed from Jul 1, 2023 | |
| 82604-600-99 | 82604060099 | 4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIALMarketed from Jul 1, 2023 · Sample package |
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)
- 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
- Rayner Surgical Inc.NDC labeler code 82604
- 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 82604-600_ffe62883-85a4-6e94-e053-6294a90ac61fSPL ID ffe62883-85a4-6e94-e053-6294a90ac61fSPL set ID f25d7a42-da2a-7310-e053-2995a90a590fRxCUI 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.
- NDC on a medical claim
N482604060000followed by a unit qualifier and the quantityPackage 82604-0600-00. 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)
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 82604-600
- What is NDC 82604-600?
- 82604-600 is the product NDC for Omidria, Phenylephrine 10.16 mg/mL; Ketorolac 2.88 mg/mL injection, solution, concentrate, listed with the FDA by Rayner Surgical Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omidria (Phenylephrine and ketorolac).
- What is the active ingredient?
- Phenylephrine, Ketorolac.
- Who is the labeler?
- Rayner Surgical Inc., NDC labeler code 82604. 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 | Omeros Corporation | 62225-600 | — |
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 | Omeros Corporation | 62225-600 |