The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Omidria
phenylephrine and ketorolac · PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL · Injection, Solution, Concentrate · Intraocular · Rayner Surgical Inc.
NDC 82604-0600-99 · 4 VIAL in 1 CARTON / 4 mL in 1 VIAL · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Hospira, Inc.United Statesmanufacture
- Patheon Manufacturing Services LLCUnited Statesmanufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA205388
- TE code
- AT
- Approval date
- May 30, 2014
- Patents / exclusivity
- 5 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 9066856*PED | Apr 23, 2034 |
| patent | 9486406*PED | Apr 23, 2034 |
| patent | 9486406 | Oct 23, 2033 |
| patent | 9066856 | Oct 23, 2033 |
| patent | 9855246 | Oct 23, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of phenylephrine and ketorolac (Injection, Solution, Concentrate)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hospira, Inc. | PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | Aug 20, 2026 | Sep 3, 2026 |
| Patheon Manufacturing Services LLC | PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | Aug 20, 2026 | Sep 3, 2026 |
| Rayner Surgical Inc. | PHENYLEPHRINE 10.16 mg/mL; KETOROLAC 2.88 mg/mL | Aug 26, 2026 | Sep 2, 2026 |
| Hospira, Inc. | PHENYLEPHRINE 2.88 mg/mL; KETOROLAC 10.16 mg/mL | Jul 22, 2026 | Aug 19, 2026 |
| Patheon Manufacturing Services LLC | PHENYLEPHRINE 2.88 mg/mL; KETOROLAC 10.16 mg/mL | Jul 22, 2026 | Aug 19, 2026 |
| Rayner Surgical Inc. | PHENYLEPHRINE 2.88 mg/mL; KETOROLAC 10.16 mg/mL | Jul 22, 2026 | Aug 19, 2026 |
| Hospira, Inc. | KETOROLAC 2.88 mg/mL; PHENYLEPHRINE 10.16 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
| Patheon Manufacturing Services LLC | KETOROLAC 2.88 mg/mL; PHENYLEPHRINE 10.16 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
| Rayner Surgical Inc. | KETOROLAC 2.88 mg/mL; PHENYLEPHRINE 10.16 mg/mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Omidria — NDC 82604-0600-99," retrieved September 3, 2026, https://drugdashboards.com/drug/82604060099.
Free to cite with attribution — see how the data is put together.