Amoxicillin and Clavulanate Potassium
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2002
Approved
Approval ID
e41387c8-2c74-4990-831f-64dc921ee138
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-1943
Application NumberANDA090227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2015
FDA Product Classification
INGREDIENTS (12)
AMOXICILLIN SODIUMActive
Quantity: 437.5 mg in 1 1
Code: 544Y3D6MYH
Classification: ACTIM
AMOXICILLINActive
Quantity: 562.5 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 62.5 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT