Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RedPharm Drug, Inc.
RedPharm Drug, Inc.
828374897
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
67296-1241Application Number
NDA012462Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
January 20, 2022AtropineActive
Code: 03J5ZE7KA5Class: ACTIBQuantity: 0.025 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
DiphenoxylateActive
Code: W24OD7YW48Class: ACTIBQuantity: 2.5 mg in 1 1