IBUPROFEN

IBUPROFEN- ibuprofen tablet, film coated
DIRECT RX

[MEDGUIDE IBUPROFEN TABLETS]

400mg (white to of white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on the other side) Bottles of 100 & 500

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 30, 50, 100 & 500

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

231
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IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-231(NDC:49483-603)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
STARCH, CORN
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-231-21 21 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 06/04/2021
Labeler — DIRECT RX (079254320)
Registrant — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 repack (72189-231)

Revised: 06/2021 DIRECT RX

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