"70518-0011-0" National Drug Code (NDC)

Guaifenesin And Pseudoephedrine Hydrochloride Extended Release 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0011-0)
(REMEDYREPACK INC.)

NDC Code70518-0011-0
Package Description18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0011-0)
Product NDC70518-0011
Product Type NameHUMAN OTC DRUG
Proprietary NameGuaifenesin And Pseudoephedrine Hydrochloride Extended Release
Non-Proprietary NameGuaifenesin, Pseudoephedrine Hydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20161121
Marketing Category NameANDA
Application NumberANDA091071
ManufacturerREMEDYREPACK INC.
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength600; 60
Strength Unitmg/1; mg/1

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