Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate PotassiumPowder for Oral Suspension, USP and Chewable Tablets, USP
Approved
Approval ID
2970fe7e-9e1f-47aa-85ad-663ee15c7e06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2011
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 and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-767
Application NumberANDA065066
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (9)
CLAVULANATE POTASSIUMActive
Quantity: 28.5 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
AMOXICILLINActive
Quantity: 200 mg in 5 mL
Code: 804826J2HU
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT