FAMOTIDINE
These highlights do not include all the information needed to use FAMOTIDINE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for FAMOTIDINE FOR ORAL SUSPENSION. FAMOTIDINE for oral suspensionInitial U.S. Approval: 1986
Approved
Approval ID
ea7287a4-75e0-39d2-5b2e-b72b7cb386b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2023
Manufacturers
FDA
Biocon Pharma Inc.
DUNS: 080000063
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FAMOTIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-113
Application NumberANDA217137
Product Classification
M
Marketing Category
C73584
G
Generic Name
FAMOTIDINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT
FAMOTIDINEActive
Quantity: 40 mg in 5 mL
Code: 5QZO15J2Z8
Classification: ACTIB