KETOROLAC TROMETHAMINE (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Ketorolac tromethamine

GENERIC: Ketorolac tromethamine

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-757-04

STRENGTH: 15 mg/mL

QTY: 15 mg/mL SDV Label

15 mg/mL label image
(click image for full-size original)

DRUG: Ketorolac tromethamine

GENERIC: Ketorolac tromethamine

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-758-11

STRENGTH: 30 mg/mL

QTY: 30 mg/mL SDV Label

30 mg/mL
(click image for full-size original)

DRUG: Ketorolac tromethamine

GENERIC: Ketorolac tromethamine

DOSAGE: Injection

ADMINSTRATION: Intramuscular, Intravenous

NDC: 64679-758-10

STRENGTH: 60 mg/2 mL (30 mg/mL)

QTY: 60 mg/2 mL (30 mg/mL) SDV Label

60 mg/2 mL
(click image for full-size original)
KETOROLAC TROMETHAMINE ketorolac tromethamine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-757
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
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-757-01 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-757-04)
1 NDC:64679-757-04 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-757-01)
2 NDC:64679-757-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-757-04)
2 NDC:64679-757-04 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-757-02)
3 NDC:64679-757-03 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-757-04)
3 NDC:64679-757-04 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-757-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077942 03/27/2007
KETOROLAC TROMETHAMINE ketorolac tromethamine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-758
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
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-758-01 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-758-11)
1 NDC:64679-758-11 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-758-01)
2 NDC:64679-758-04 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-758-11)
2 NDC:64679-758-11 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-758-04)
3 NDC:64679-758-02 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-758-10)
3 NDC:64679-758-10 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-758-02)
4 NDC:64679-758-06 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-758-10)
4 NDC:64679-758-10 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-758-06)
5 NDC:64679-758-05 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64679-758-10)
5 NDC:64679-758-10 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64679-758-05)
6 NDC:64679-758-03 15 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
6 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (64679-758-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077942 03/27/2007
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-757), ANALYSIS (64679-758), MANUFACTURE (64679-757), MANUFACTURE (64679-758), LABEL (64679-757), LABEL (64679-758), PACK (64679-757), PACK (64679-758)

Revised: 11/2019 Wockhardt USA LLC.

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