Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals
RedPharm Drug Inc.
831227801
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
NDC Product Code
67296-0538Application Number
ANDA078558Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 23, 2010polyvinyl alcoholInactive
Code: 532B59J990Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
stearic acidInactive
Code: 4ELV7Z65APClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
talcInactive
Code: 7SEV7J4R1UClass: IACT