Ketorolac Tromethamine (Page 9 of 9)

Package/Label Display Panel

NDC: 70934-029-15

Label
(click image for full-size original)
KETOROLAC TROMETHAMINE
ketorolac tromethamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-029(NDC:0093-0314)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 93;314
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-029-15 15 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70934-029-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:70934-029-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074754 03/17/2017
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-029)

Revised: 12/2020 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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