Amoxicillin
AMOXICILLIN TABLETS, USP 875 mgRx onlyRevised: August 2008
Approved
Approval ID
01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0628
Application NumberANDA065255
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2011
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT