NDC 62225-600

Omidria

Phenylephrine And Ketorolac

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 Phenylephrine; Ketorolac.

• Product ID: 62225-600_ac86fe7c-f008-4d9d-ac5d-bc8b23972cdd
• NDC: 62225-600
• Product Type: Human Prescription Drug
• Proprietary Name: Omidria
• Generic Name: Phenylephrine And Ketorolac
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAOCULAR
• Marketing Start Date: 2014-06-13
• Marketing Category: NDA / NDA
• Application Number: NDA205388
• Labeler Name: Omeros Corporation
• Substance Name: PHENYLEPHRINE; KETOROLAC
• Active Ingredient Strength: 10 mg/mL; mg/mL
• Pharm Classes: alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 62225-600-00

1 VIAL in 1 CARTON (62225-600-00) > 4 mL in 1 VIAL

• Marketing Start Date: 2014-06-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62225-600-04 [62225060004]

Omidria INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA205388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-06-13

NDC 62225-600-99 [62225060099]

Omidria INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA205388
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-17

NDC 62225-600-10 [62225060010]

Omidria INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA205388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-06-13

NDC 62225-600-00 [62225060000]

Omidria INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA205388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-06-13

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE	10.16 mg/mL

OpenFDA Data

• SPL SET ID: 21470688-4e81-4ea5-ac38-f72e10552e7e
• Manufacturer:
  • Omeros Corporation
• UNII:
  • YZI5105V0L
  • 1WS297W6MV
• RxNorm Concept Unique ID - RxCUI:
  • 1540230
  • 1540235
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Cyclooxygenase Inhibitor [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721
  • N0000175939

Pharmacological Class

• alpha-1 Adrenergic Agonist [EPC]
• Adrenergic alpha1-Agonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Cyclooxygenase Inhibitor [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• alpha-1 Adrenergic Agonist [EPC]
• Adrenergic alpha1-Agonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Cyclooxygenase Inhibitor [EPC]