IBUPROFEN 600 MG TABLETS

IBUPROFEN 600 MG TABLETS

Drug Labeling and Warnings

Drug Details

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

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IBUPROFEN 600 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 4, 6, 10, 15, 20, 21, 24, 30, 40, 60, 90, 100 and 500.

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IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43063-867(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: 43063-867-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
2NDC: 43063-867-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2018
3NDC: 43063-867-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
4NDC: 43063-867-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
5NDC: 43063-867-2121 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
6NDC: 43063-867-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2018
7NDC: 43063-867-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2018
8NDC: 43063-867-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2018
9NDC: 43063-867-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
10NDC: 43063-867-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
11NDC: 43063-867-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
12NDC: 43063-867-044 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2019
13NDC: 43063-867-82500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2020
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(43063-867)

Revised: 2/2020
 
PD-Rx Pharmaceuticals, Inc.


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