"53002-1192-1" National Drug Code (NDC)

Sertraline Hydrochloride 10 TABLET in 1 BOTTLE (53002-1192-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1192-1
Package Description10 TABLET in 1 BOTTLE (53002-1192-1)
Product NDC53002-1192
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSertraline Hydrochloride
Non-Proprietary NameSertraline Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20160721
Marketing Category NameANDA
Application NumberANDA077397
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameSERTRALINE HYDROCHLORIDE
Strength50
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]

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