Loperamide Hydrochloride
LOPERAMIDE HYDROCHLORIDE Capsules
Approved
Approval ID
374ae1e9-7985-40d6-82b0-55b2d7850c62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
JUBILANT CADISTA PHARMACEUTICALS INC.
DUNS: 022490515
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loperamide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-781
Application NumberANDA217840
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loperamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2022
FDA Product Classification
INGREDIENTS (12)
Loperamide HydrochlorideActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT