DexMoxiKetor PF
Approved
Approval ID
6bb7c6fb-ac41-764c-e053-2991aa0a3b60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2018
Manufacturers
FDA
ImprimisRx NJ
DUNS: 931390178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone - Moxifloxacin - Ketorolac PF
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70261-513
Product Classification
G
Generic Name
Dexamethasone - Moxifloxacin - Ketorolac PF
Product Specifications
Route of AdministrationINTRAOCULAR
Effective DateMay 8, 2018
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
Drug Labeling Information
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 1/1/2018
Store at 20° to 25° C (68° to 77° F)