"70518-3915-0" National Drug Code (NDC)

Diphenoxylate Hydrochloride And Atropine Sulfate 30 TABLET in 1 BLISTER PACK (70518-3915-0)
(REMEDYREPACK INC.)

NDC Code70518-3915-0
Package Description30 TABLET in 1 BLISTER PACK (70518-3915-0)
Product NDC70518-3915
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date20231116
Marketing Category NameANDA
Application NumberANDA213413
ManufacturerREMEDYREPACK 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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