IBUPROFEN- ibuprofen tablet, film coated 
PD-Rx Pharmaceuticals, Inc.

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IBUPROFEN 400 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 6, 10, 20, 30, 40, 90 and 500

400mg label

image

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-872(NDC:49483-602)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 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
ShapeROUNDSize13mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-872-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2019
2NDC:43063-872-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2019
3NDC:43063-872-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2018
4NDC:43063-872-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2018
5NDC:43063-872-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/07/2018
6NDC:43063-872-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2019
7NDC:43063-872-82500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-872)

Revised: 6/2020
Document Id: a7473592-080a-10a4-e053-2995a90ac0ca
Set id: ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3
Version: 15
Effective Time: 20200604
 
PD-Rx Pharmaceuticals, Inc.