Ketorolac Tromethamine
KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx only
Approved
Approval ID
86142f73-00fc-48d6-8383-3c28bd0b5832
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2022
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
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
NDC Product Code35356-696
Application NumberANDA074754
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 8, 2019
Generic NameKetorolac Tromethamine
INGREDIENTS (9)
KETOROLAC TROMETHAMINEActive
Quantity: 10 mg in 1 1
Code: 4EVE5946BQ
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT