Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Stat Rx USA
Stat Rx USA
786036330
Products1
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
NDC Product Code
16590-080Application Number
ANDA086727Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 24, 2010MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 1 1