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 ID70261-513_6bb7c6fb-ac42-764c-e053-2991aa0a3b60
NDC70261-513
Product TypeHuman Prescription Drug
Proprietary NameDexMoxiKetor PF
Generic NameDexamethasone - Moxifloxacin - Ketorolac Pf
Dosage FormInjection, Solution
Route of AdministrationINTRAOCULAR
Marketing Start Date2018-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameImprimisRx NJ
Substance NameMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE; DEXAMETHASONE SODIUM PHOSPHATE; KETOROLAC TROMETHAMINE
Active Ingredient Strength1 mg/mL; mg/mL; mg/mL
Pharm ClassesQuinolone 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70261-513-01

1 mL in 1 VIAL, SINGLE-USE (70261-513-01)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70261-513-01 [70261051301]

DexMoxiKetor PF INJECTION, SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE.5 mg/mL

OpenFDA Data

SPL SET ID:6bb7c6fb-ac41-764c-e053-2991aa0a3b60
Manufacturer
UNII

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]

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