Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V
Approved
Approval ID
24077113-11b2-4cde-afa7-1a1e364173c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5592
Application NumberANDA213413
Product Classification
M
Marketing Category
C73584
G
Generic Name
diphenoxylate hydrochloride and atropine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2020
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB