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NDC 62225-0600-00 Omidria 2.88; 10.16 mg/mL; mg/mL Details
Omidria 2.88; 10.16 mg/mL; mg/mL
Omidria is a INTRAOCULAR INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Omeros Corporation. The primary component is KETOROLAC; PHENYLEPHRINE.
Product Information
| NDC | 62225-0600 |
|---|---|
| Product ID | 62225-600_efc8de6e-47da-6111-e053-2a95a90a34e4 |
| Associated GPIs | 86789902602020 |
| GCN Sequence Number | 072405 |
| GCN Sequence Number Description | phenylephrine/ketorolac VIAL 1 %-0.3 % INTRAOCULR |
| HIC3 | Q2O |
| HIC3 Description | EYE MYDRIATIC AND NSAID COMBINATIONS |
| GCN | 36617 |
| HICL Sequence Number | 041164 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/KETOROLAC TROMETHAMINE |
| Brand/Generic | Brand |
| Proprietary Name | Omidria |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | phenylephrine and ketorolac |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAOCULAR |
| Active Ingredient Strength | 2.88; 10.16 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | KETOROLAC; PHENYLEPHRINE |
| Labeler Name | Omeros Corporation |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA205388 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62225-0600-00 (62225060000)
| NDC Package Code | 62225-600-00 |
|---|---|
| Billing NDC | 62225060000 |
| Package | 1 VIAL in 1 CARTON (62225-600-00) / 4 mL in 1 VIAL |
| Marketing Start Date | 2014-06-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |