Ketorolac Tromethamine (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — VIAL

NDC 71205-582 -01

Ketorolac Tromethamine Injection, USP

30 mg/mL

FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY

1 mL Single-Dose Vial

71205-582-01
(click image for full-size original)
KETOROLAC TROMETHAMINE ketorolac tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-582(NDC:72611-722)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketorolac tromethamine (ketorolac) ketorolac tromethamine 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
sodium chloride
hydrochloric acid
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-582-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71205-582-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204216 01/21/2020
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (71205-582)

Revised: 07/2021 Proficient Rx LP

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