Mydriatic-4
Approved
Approval ID
6e11c346-99d6-e440-e053-2991aa0a79b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2018
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.
Tropicamide - Proparacine - Phenylephrine - Ketorolac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71384-632
Product Classification
G
Generic Name
Tropicamide - Proparacine - Phenylephrine - Ketorolac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 1, 2018
FDA Product Classification
INGREDIENTS (4)
TROPICAMIDEActive
Quantity: 10 mg in 1 mL
Code: N0A3Z5XTC6
Classification: ACTIB
PROPARACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: U96OL57GOY
Classification: ACTIB
KETOROLAC TROMETHAMINEActive
Quantity: 5 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB