Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium
Approved
Approval ID
d74e93e5-11c9-434e-a60c-4a4f911dd0f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 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 and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-546
Application NumberANDA065066
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2007
FDA Product Classification
INGREDIENTS (8)
Clavulanate PotassiumActive
Quantity: 57 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIB
AmoxicillinActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
succinic acidInactive
Code: AB6MNQ6J6L
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT