IBUPROFEN- ibuprofen tablet, film coated 
NuCare Pharmaceuticals,Inc.

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HOW SUPPLIED

NDC 68071-4009-7 Bottles of 15

NDC 68071-4009-2 Botles of 20

NDC 68071-4009-1 Bottles of 21

NDC 68071-4009-3 Bottles of 30

NDC 68071-4009-4 Bottles of 40

NDC 68071-4009-5 Bottles of 50

NDC 68071-4009-6 Bottles of 60

NDC 68071-4009-9 Bottles of 90

600mg Ibuprofen Package Label

pdp

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68071-4009(NDC:49483-603)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4009-715 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
2NDC:68071-4009-220 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
3NDC:68071-4009-121 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
4NDC:68071-4009-330 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
5NDC:68071-4009-440 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
6NDC:68071-4009-550 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
7NDC:68071-4009-660 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
8NDC:68071-4009-990 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-4009)

Revised: 10/2019
Document Id: 94f9c2ef-6d98-d6c4-e053-2995a90ab7f1
Set id: 54b25106-5580-119d-e054-00144ff88e88
Version: 2
Effective Time: 20191015
 
NuCare Pharmaceuticals,Inc.