Basic Information
ibuprofen
11788-008
Regulatory Information
11788-008
ANDA202413
C73584
May 13, 2020
USA
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg
HUMAN PRESCRIPTION DRUG LABEL
8
Company Information
079674526
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYVINYL ALCOHOL
Code: 532B59J990
Class Code: IACT
POLYETHYLENE GLYCOL 1000
Code: U076Q6Q621
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
LECITHIN, SOYBEAN
Code: 1DI56QDM62
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
Active Moieties
IBUPROFEN
Code: WK2XYI10QM