Diphenoxylate Hydrochloride and Atropine Sulfate
Approved
Approval ID
4f457a86-b920-5b53-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2022
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-1241
Application NumberNDA012462
Product Classification
M
Marketing Category
C73605
G
Generic Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (8)
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB