NDC 71384-513

Dex-Moxi-Ketor

Dexamethasone Phosphate - Moxifloxacin - Ketorolac Tromethamine

Dex-Moxi-Ketor is a Ophthalmic Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Dexamethasone Sodium Phosphate; Moxifloxacin Hydrochloride Monohydrate; Ketorolac Tromethamine.

• Product ID: 71384-513_638a4320-9c22-4122-e053-2991aa0af758
• NDC: 71384-513
• Product Type: Human Prescription Drug
• Proprietary Name: Dex-Moxi-Ketor
• Generic Name: Dexamethasone Phosphate - Moxifloxacin - Ketorolac Tromethamine
• Dosage Form: Injection, Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-01-05
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: DEXAMETHASONE SODIUM PHOSPHATE; MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE; KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-513-01

20 VIAL, SINGLE-USE in 1 BOX (71384-513-01) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-513-01 [71384051301]

Dex-Moxi-Ketor INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-01-05
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-10

Drug Details

Active Ingredients

Ingredient	Strength
DEXAMETHASONE SODIUM PHOSPHATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 62fff769-95d6-0908-e053-2a91aa0a732d
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • B8956S8609
  • AI9376Y64P
  • 4EVE5946BQ

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Cyclooxygenase Inhibitor [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]