"57483-270-01" National Drug Code (NDC)

Crcle Guaifenesin Extended-release Tablets, 600 Mg 5 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACK
(Innovus Pharmaceuticals, Inc.)

NDC Code57483-270-01
Package Description5 BLISTER PACK in 1 CARTON (57483-270-01) / 20 TABLET in 1 BLISTER PACK
Product NDC57483-270
Product Type NameHUMAN OTC DRUG
Proprietary NameCrcle Guaifenesin Extended-release Tablets, 600 Mg
Non-Proprietary NameGuaifenesin Extended-release
Dosage FormTABLET
UsageORAL
Start Marketing Date20200910
Marketing Category NameANDA
Application NumberANDA213420
ManufacturerInnovus Pharmaceuticals, Inc.
Substance NameGUAIFENESIN
Strength600
Strength Unitmg/1
Pharmacy ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]

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