Lomotil
Approved
Approval ID
4f1bbc1d-9585-20b2-e054-00144ff88e88
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.
Lomotil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1210
Application NumberNDA012462
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lomotil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (8)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB