Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate hydrochloride and atropine sulfate tablets, for oral use, C-V
Approved
Approval ID
5117f26c-488f-4ba6-b115-22baf12557f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Bayshore Pharmaceuticals, LLC
DUNS: 968737416
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-107
Application NumberANDA210819
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2019
FDA Product Classification
INGREDIENTS (7)
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB