"53002-3401-2" National Drug Code (NDC)

Diphenoxylate Hydrochloride And Atropine Sulfate 20 TABLET in 1 BOTTLE (53002-3401-2)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-3401-2
Package Description20 TABLET in 1 BOTTLE (53002-3401-2)
Product NDC53002-3401
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date20200315
Marketing Category NameANDA
Application NumberANDA213413
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Strength.025; 2.5
Strength Unitmg/1; mg/1
Pharmacy ClassesAnticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA ScheduleCV

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