"0378-0415-10" National Drug Code (NDC)

Diphenoxylate Hydrochloride And Atropine Sulfate 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0415-10)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0415-10
Package Description1000 TABLET in 1 BOTTLE, PLASTIC (0378-0415-10)
Product NDC0378-0415
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date19771117
End Marketing Date20240331
Marketing Category NameANDA
Application NumberANDA085762
ManufacturerMylan 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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