KETOROLAC TROMETHAMINE (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL — Container Label

Rx only NDC 55150-339-01
Ketorolac
Tromethamine
Injection, USP
15 mg per mL
For Intravenous or
Intramuscular Use
1 mL Single-Dose Vial

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL -- Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL — Container-Carton (1 Vial)

Rx only NDC 55150-339-01
Ketorolac
Tromethamine
Injection, USP
15 mg per mL
For Intravenous or
Intramuscular Use
Dispense the enclosed
Medication Guide to
each patient.
1 mL Single-Dose Vial
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL -- Container-Carton (1 Vial)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL — Container-Carton (25 Vials)

Rx only NDC 55150-339-25
Ketorolac
Tromethamine
Injection, USP
15 mg per mL
For Intravenous or Intramuscular Use
Dispense the enclosed Medication Guide to each patient.
25 x 1 mL Single-Dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-15 mg per mL -- Container-Carton (25 Vials)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL — Container Label

Rx only NDC 55150-340-01
Ketorolac
Tromethamine
Injection, USP
30 mg per mL
For Intravenous or
Intramuscular Use
1 mL Single-Dose Vial

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL -- Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL — Container-Carton (1 Vial)

Rx only NDC 55150-340-01
Ketorolac
Tromethamine
Injection, USP
30 mg per mL
For Intravenous or
Intramuscular Use
Dispense the enclosed
Medication Guide to each patient.
1 mL Single-Dose Vial
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL -- Container-Carton (1 Vial)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL — Container-Carton (10 Vials)

Rx only NDC 55150-340-10
Ketorolac
Tromethamine
Injection, USP
30 mg per mL
For Intravenous or Intramuscular Use
Dispense the enclosed Medication Guide to each patient.
10 x 1 mL Single-Dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL -- Container-Carton (10 Vials)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL — Container-Carton (25 Vials)

Rx only NDC 55150-340-25
Ketorolac
Tromethamine
Injection, USP
30 mg per mL
For Intravenous or Intramuscular Use
Dispense the enclosed Medication Guide to each patient.
25 x 1 mL Single-Dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-30 mg per mL -- Container-Carton (25 Vials)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) — Container Label

Rx only NDC 55150-341-01
Ketorolac
Tromethamine
Injection, USP
60 mg per 2 mL
(30 mg/mL)
For Intramuscular Use Only
2 mL Single-Dose Vial

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) -- Container Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) — Container-Carton (1 Vial)

Rx only NDC 55150-341-01
Ketorolac
Tromethamine
Injection, USP
60 mg per 2 mL
(30 mg/mL)
For Intramuscular
Use Only
Dispense the enclosed
Medication Guide to
each patient.
2 mL Single-Dose Vial
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) -- Container-Carton (1 Vial)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) — Container-Carton (25 Vials)

Rx only NDC 55150-341-25
Ketorolac
Tromethamine
Injection, USP
60 mg per 2 mL
(30 mg/mL)
For Intramuscular Use Only
Dispense the enclosed Medication Guide to each patient.
25 x 2 mL Single-Dose Vials
AUROMEDICS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-60 mg per 2 mL (30 mg/mL) -- Container-Carton (25 Vials)
(click image for full-size original)

KETOROLAC TROMETHAMINE ketorolac tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-339
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-339-01 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 (55150-339-01)
2 NDC:55150-339-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-339-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212939 10/20/2020
KETOROLAC TROMETHAMINE ketorolac tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-340
Route of Administration INTRAMUSCULAR, INTRAVENOUS 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
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-340-01 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 (55150-340-01)
2 NDC:55150-340-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-340-10)
3 NDC:55150-340-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
3 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-340-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212939 10/20/2020
KETOROLAC TROMETHAMINE ketorolac tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55150-341
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 60 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-341-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-341-01)
2 NDC:55150-341-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-341-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212939 10/20/2020
Labeler — AuroMedics Pharma LLC (968961354)
Establishment
Name Address ID/FEI Operations
Eugia Pharma Specialities Limited 650498244 ANALYSIS (55150-339), ANALYSIS (55150-340), ANALYSIS (55150-341), MANUFACTURE (55150-339), MANUFACTURE (55150-340), MANUFACTURE (55150-341)

Revised: 10/2021 AuroMedics Pharma LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.