NDC Code(s) : 61786-055-52
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ketorolac TromethamineKETOROLAC TROMETHAMINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-055(NDC:0409-3795)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
(KETOROLAC - UNII:YZI5105V0L) 		KETOROLAC TROMETHAMINE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)4.35 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-055-5225 mL in 1 CARTON Type 0: Not a Combination Product05/11/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074802 11/05/2015 02/03/2017

PRINCIPAL DISPLAY PANEL

DRUG: Ketorolac Tromethamine

GENERIC: KETOROLAC TROMETHAMINE

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAMUSCULAR

NDC: 61786-055-52

PACKAGING: 25 mL in 1 CARTON

ACTIVE INGREDIENT(S):

  • KETOROLAC TROMETHAMINE 30mg in 1mL

INACTIVE INGREDIENT(S):

  • ALCOHOL
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
  • SODIUM CHLORIDE
  • WATER

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