"53345-020-01" National Drug Code (NDC)

Night Cold Flu Cough And Allergy 1 BAG in 1 BOX (53345-020-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
(Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.)

NDC Code53345-020-01
Package Description1 BAG in 1 BOX (53345-020-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product NDC53345-020
Product Type NameHUMAN OTC DRUG
Proprietary NameNight Cold Flu Cough And Allergy
Non-Proprietary NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage FormCAPSULE, LIQUID FILLED
UsageORAL
Start Marketing Date20130529
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart341
ManufacturerHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Strength325; 10; 6.25; 5
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesAdrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]

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