ACULAR
Approved
Approval ID
8014fa52-6180-4365-8285-0943a036a6f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-463
Application NumberNDA019700
Product Classification
M
Marketing Category
C73594
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 20, 2009
FDA Product Classification
INGREDIENTS (8)
OCTOXYNOL-40Inactive
Code: 9T1C662FKS
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 5 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT