Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products1
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
NDC Product Code
53002-3401Application Number
ANDA213413Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 25, 2020AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 1 1