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Dex-Moxi-Ketor

Approved
Approval ID

62fff769-95d6-0908-e053-2a91aa0a732d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 10, 2020

Manufacturers
FDA

Imprimis NJOF, LLC

DUNS: 080431967

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dexamethasone Phosphate - Moxifloxacin - Ketorolac Tromethamine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71384-513
Product Classification
G
Generic Name
Dexamethasone Phosphate - Moxifloxacin - Ketorolac Tromethamine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 10, 2020
FDA Product Classification

INGREDIENTS (3)

DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 1 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
KETOROLAC TROMETHAMINEActive
Quantity: 0.4 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIM
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATEActive
Quantity: 0.5 mg in 1 mL
Code: B8956S8609
Classification: ACTIM

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Dex-Moxi-Ketor - FDA Drug Approval Details