Diphenoxylate Hcl and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate (Diphenoxylate Hydrochloride and Atropine Sulfate) tablet
Approved
Approval ID
542b6ceb-7ad4-4d0d-b604-79bd1f567d79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2010
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hcl and Atropine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-080
Application NumberANDA086727
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenoxylate Hcl and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2010
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Atropine SulfateActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Diphenoxylate HydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB