Ibuprofen tablet, coated

Ingredients and appearance - Product information

Ibuprofen tablet, coated- Ibuprofen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-7892
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 200 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Ferric oxide red ( UNII: 1K09F3G675)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polyvinyl alcohol, unspecified ( UNII: 532B59J990)
Starch, corn ( UNII: O8232NY3SJ)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color brown Shape ROUND
Size 10 mm Imprint Code 114
Score 1

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 11822-7892-5 100 in 1 BOTTLE 2020/06/01
2 NDC: 11822-7892-0 24 in 1 BOTTLE 2020/06/01
3 NDC: 11822-7892-9 500 in 1 BOTTLE 2020/06/01
4 NDC: 11822-7892-2 50 in 1 BOTTLE 2020/06/01
5 NDC: 11822-7892-7 200 in 1 BOTTLE 2020/06/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091239 USA 2020/06/01

Labeler - RITE AID CORPORATION( 014578892)

Establishment

Name ID/FEI Business Operations
RITE AID CORPORATION 014578892 manufacture( 11822-7892)