"75826-107-03" National Drug Code (NDC)

Diphenoxylate Hydrochloride And Atropine Sulfate 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03)
(Winder Laboratories LLC)

NDC Code75826-107-03
Package Description100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03)
Product NDC75826-107
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Non-Proprietary NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTABLET
UsageORAL
Start Marketing Date20220430
Marketing Category NameANDA
Application NumberANDA211362
ManufacturerWinder Laboratories 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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