Lomotil
Approved
Approval ID
d2b171be-ac59-48ec-84da-03d3f2d34ca6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0427
Application NumberNDA012462
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diphenoxylate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2009
FDA Product Classification
INGREDIENTS (8)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB