Flurbiprofen (Page 7 of 7)

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PDP
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FLURBIPROFEN flurbiprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2480(NDC:0093-0711)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLURBIPROFEN (FLURBIPROFEN) FLURBIPROFEN 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYSORBATE 80
TITANIUM DIOXIDE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 93;711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2480-4 14 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-2480-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074431 06/02/1995
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2480)

Revised: 07/2021 NuCare Pharmaceuticals,Inc.

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