"55758-304-04" National Drug Code (NDC)

Dolex Children 1 BOTTLE in 1 CARTON (55758-304-04) > 118 mL in 1 BOTTLE
(Pharmadel LLC)

NDC Code55758-304-04
Package Description1 BOTTLE in 1 CARTON (55758-304-04) > 118 mL in 1 BOTTLE
Product NDC55758-304
Product Type NameHUMAN OTC DRUG
Proprietary NameDolex Children
Non-Proprietary NameIbuprofen
Dosage FormLIQUID
UsageORAL
Start Marketing Date20200807
Marketing Category NameANDA
Application NumberANDA210602
ManufacturerPharmadel LLC
Substance NameIBUPROFEN
Strength100
Strength Unitmg/100mL
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]

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