Loperamide Hydrochloride
Loperamide Hydrochloride
Approved
Approval ID
619c6d6a-7eca-4f89-9913-d4e9388515fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2022
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6208
Application NumberANDA215001
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loperamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LOPERAMIDE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT