"55319-197-20" National Drug Code (NDC)

Ibuprofen Pm 1 BOTTLE, PLASTIC in 1 BOX (55319-197-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC
(Family Dollar (FAMILY WELLNESS))

NDC Code55319-197-20
Package Description1 BOTTLE, PLASTIC in 1 BOX (55319-197-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC
Product NDC55319-197
Product Type NameHUMAN OTC DRUG
Proprietary NameIbuprofen Pm
Non-Proprietary NameDiphenhydramine Citrate, Ibuprofen
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20240301
Marketing Category NameANDA
Application NumberANDA211404
ManufacturerFamily Dollar (FAMILY WELLNESS)
Substance NameDIPHENHYDRAMINE CITRATE; IBUPROFEN
Strength38; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]

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