NDC 70261-513

DexMoxiKetor PF

Dexamethasone - Moxifloxacin - Ketorolac Pf

DexMoxiKetor PF is a Intraocular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Imprimisrx Nj. The primary component is Moxifloxacin Hydrochloride Monohydrate; Dexamethasone Sodium Phosphate; Ketorolac Tromethamine.

• Product ID: 70261-513_6bb7c6fb-ac42-764c-e053-2991aa0a3b60
• NDC: 70261-513
• Product Type: Human Prescription Drug
• Proprietary Name: DexMoxiKetor PF
• Generic Name: Dexamethasone - Moxifloxacin - Ketorolac Pf
• Dosage Form: Injection, Solution
• Route of Administration: INTRAOCULAR
• Marketing Start Date: 2018-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: ImprimisRx NJ
• Substance Name: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE; DEXAMETHASONE SODIUM PHOSPHATE; KETOROLAC TROMETHAMINE
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor 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: 2019-12-31

Packaging

NDC 70261-513-01

1 mL in 1 VIAL, SINGLE-USE (70261-513-01)

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

NDC SPL Data Element Entries

NDC 70261-513-01 [70261051301]

DexMoxiKetor PF INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 6bb7c6fb-ac41-764c-e053-2991aa0a3b60
• Manufacturer:
  • ImprimisRx NJ
• UNII:
  • B8956S8609
  • AI9376Y64P
  • 4EVE5946BQ

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor 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]