Amoxicillin and Clavulanate Potassium
Amoxicillin and Clavulanate Potassium
Approved
Approval ID
7fbe32f3-fa36-4271-85b4-71c4d6c15d95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0716
Application NumberANDA065109
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2011
FDA Product Classification
INGREDIENTS (13)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
AmoxicillinActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
Clavulanate PotassiumActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
triethyl citrateInactive
Code: 8Z96QXD6UM
Classification: IACT