Amoxicillin
Amoxicillin Capsules, Tablets and Powder for Oral Suspension, USP
Approved
Approval ID
ee3875c6-5c49-4386-8ad2-5fe3208ed9e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-544
Application NumberANDA065228
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2007
FDA Product Classification
INGREDIENTS (10)
AmoxicillinActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT