Famotidine
Famotidine for Oral Suspension, USP
Approved
Approval ID
a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2017
Manufacturers
FDA
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
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 Code43386-500
Application NumberANDA201695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2017
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FAMOTIDINEActive
Quantity: 40 mg in 5 mL
Code: 5QZO15J2Z8
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT