Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg22742275Rx only
Approved
Approval ID
d0459c2a-2de1-4f19-acee-c1bd664f3342
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-215
Application NumberANDA065096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (11)
amoxicillinActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
clavulanate potassiumActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
Amoxicillin and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-214
Application NumberANDA065101
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (11)
clavulanate potassiumActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
amoxicillinActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT