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Amerisource Bergen Anti-Diarrheal Anti-Gas Drug Facts
Approved
Approval ID
5dae1247-3ec0-495e-b3f2-1c1555141617
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Amerisource Bergen
DUNS: 007914906
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
loperamide hydrochloride, simethicone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46122-620
Application NumberANDA209837
Product Classification
M
Marketing Category
C73584
G
Generic Name
loperamide hydrochloride, simethicone
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (10)
LOPERAMIDE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIMETHICONEActive
Quantity: 125 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT