"76385-107-01" National Drug Code (NDC)

Diphenoxylate Hydrochloride And Atropine Sulfate 100 TABLET in 1 BOTTLE (76385-107-01)
(Bayshore Pharmaceuticals, LLC)

NDC Code76385-107-01
Package Description100 TABLET in 1 BOTTLE (76385-107-01)
Product NDC76385-107
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date20190515
Marketing Category NameANDA
Application NumberANDA210819
ManufacturerBayshore Pharmaceuticals, LLC
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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