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amoxicillin and clavulanate potassium

Prescription ANDA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
amoxicillin and clavulanate potassium
Generic name
amoxicillin and clavulanate potassium
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Chartwell RX, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Amoxicillin 200 mg/1 617296 View
Amoxicillin 400 mg/1 617296 View
Clavulanate Potassium 28.5 mg/1 617296 View
Clavulanate Potassium 57 mg/1 617296 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Penicillin-class Antibacterial [EPC] EPC All 38 members
Penicillins [CS] CS All 38 members
beta Lactamase Inhibitor [EPC] EPC All 15 members
beta Lactamase Inhibitors [MoA] MoA All 15 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
065205
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 9, 2005
Sponsor
CHARTWELL RX
Products on application
2
Submissions recorded
11
Products approved under application 065205.
Product Trade name Form Strength Ingredient Status TE Flags
065205-001 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE AMOXICILLIN; CLAVULANATE POTASSIUM Prescription —
065205-002 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE AMOXICILLIN; CLAVULANATE POTASSIUM Prescription — RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
No
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 065205.
Type No. Action Status Date Review
Supplement 30 Labeling Approved May 1, 2024 Standard
Supplement 26 Labeling Approved April 24, 2024 Standard
Supplement 19 Labeling Approved April 24, 2024 Standard
Supplement 13 Manufacturing (CMC) Approved October 20, 2014 —
Supplement 17 Labeling Approved September 26, 2014 Standard
Supplement 8 Labeling Approved July 24, 2013 —
Supplement 15 Labeling Approved July 8, 2013 Standard
Supplement 7 Labeling Approved July 29, 2011 —
Supplement 6 Labeling Approved July 20, 2010 —
Supplement 5 Labeling Approved October 28, 2009 —
Original application 1 Approved February 9, 2005 —

Review documents

  • 0 · Original application · July 31, 2008

Adverse event reports

Source: openFDA FAERS
101,548
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: AMOXICILLIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
62135-104-20 62135-104 Chartwell RX, LLC 20 TABLET, CHEWABLE in 1 BOTTLE (62135-104-20) July 21, 2026
62135-105-20 62135-105 Chartwell RX, LLC 20 TABLET, CHEWABLE in 1 BOTTLE (62135-105-20) July 21, 2026
62135-104 62135-104 Chartwell RX, LLC — March 22, 2005
62135-105 62135-105 Chartwell RX, LLC — February 10, 2005

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.