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Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL Powder, For Suspension, 100 mL — NDC 00093-2277-73 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL Powder, For Suspension, 100 mL — NDC 0093-2277-73 (Billing 00093-2277-73)

by Teva Pharmaceuticals USA, Inc. · 100 mL in 1 BOTTLE

This is a package of 100 mL of Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL Powder, For Suspension from Teva Pharmaceuticals USA, Inc., marketed since Jan 2005 and currently FDA-listed; retail pharmacies pay about $0.0481 per mL (NADAC). It is this product's only package size.

NDC 00093-2277-73
🏷️ FDA NDC (as labeled) 0093-2277-73 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0093-2277-73
Product NDC 0093-2277
11-digit billing NDC 00093227773
NCPDP billing unit ML — per mL (volume)
RxCUI 562508, 617296, 617423, 617430
UNII 804826J2HU, Q42OMW3AT8
UPC 0300932274341, 0300932275348
Application # ANDA065089
SPL Set ID 963e7bea-ff5d-420a-9cb2-e4aefb534b33
Established class (EPC) Penicillin-class Antibacterial; beta Lactamase Inhibitor
Mechanism of action beta Lactamase Inhibitors
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-01-13
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance AMOXICILLIN; CLAVULANATE POTASSIUM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 01990002201915
GPI class Amoxicillin-Pot Clavulanate
GCN Seq No 026720
GCN 67154
HICL code 003962
Ingredient (HICL) Amoxicillin/Potassium Clav
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.08
AHFS class Aminopenicillin Antibiotics
FDB label name AMOX-CLAV 200-28.5 MG/5 ML SUS
FDB brand name Amoxicillin-Clavulanate Potass
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 026720
  • GCN: 67154
  • GPI-14 (Medi-Span): 01990002201915
  • HICL (First Databank): 003962
  • AHFS class code: 08:12.16.08
  • RxCUI (RxNorm): 562508
Why two NDCs? The FDA registers this code as 0093-2277-73 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00093-2277-73. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
How it works beta Lactamase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AMOX-CLAV 200-28.5 MG/5 ML SUS Ingredient Amoxicillin/Potassium Clav
📖 What it is MedlinePlus · NLM

Amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by stopping bacteria from breaking down amoxicillin. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists a...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as those of the lungs, sinuses, ears, skin and urinary tract. Some forms are for specific infections, like middle ear infections in young childr...
  • You can take it with or without food. But taking it at the start of a meal helps you absorb the clavulanate and often eases stomach upset. Follow your prescriber's directions for y...
  • Diarrhea, loose stools, nausea and mild rash are the most common. Vomiting and vaginal yeast infections can also happen. Call us if symptoms are severe or don't settle.
  • Get urgent help for trouble breathing, swelling, hives or a spreading or blistering rash. Call your doctor if you have yellow skin or eyes, or watery or bloody diarrhea, even weeks...
📖 Read our full Amoxicillin / Clavulanate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.048 $4.81 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.1506 $15.06 / 100 ml
Medicare drug plans payPart D · Q2 2026 $0.0932 $9.32 / 100 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Jan 2026 Sep 2026 $0.078 $0.047
▼ Down 17% over the last 23 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00093-2277-73 You're viewing this Main listing 100 mL in 1 BOTTLE 2005-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mLthis 00093-2277-73 Teva 100 ml $0.048 AB Availability likely —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 00143-9981-01 Hikma 100 ml $0.048 AB Availability likely —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 00781-6102-46 Sandoz 100 ml $0.048 AB Availability likely —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 42571-0163-47 Micro 100 ml $0.048 AB Discontinued —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 65862-0533-01 Aurobindo 100 ml $0.048 AB Availability likely —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 16714-0292-01 NorthStar 50 ml $0.070 AB Availability likely +46%
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 50090-5932-00 A-S 100 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 50090-6222-00 A-S 100 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 68071-3807-01 NuCare 100 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 68788-8306-01 Preferred 100 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 76420-0859-01 Asclemed 100 ml — AB FDA listed —
Amoxicillin and Clavulanate Potassium 200 mg/5mL; 28.5 mg/5mL 85534-0080-00 HAWAII 50 ml — AB FDA listed —
amoxicillin and clavulanate potassium 200 mg/5mL; 28.5 mg/5mL 62135-0093-01 Chartwell 100 ml — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2005
On the market since
Jan 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeOval
Imprint93;22;75
Size22 mm
ScoringScored — splits in 2
FlavorOrange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA065089 (ANDA)
Labeler code00093
First marketedJan 2005
Product typeHuman Prescription Drug
Portfolio504 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis .

Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. Urinary Tract Infections – caused by beta–lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species.

Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta–lactamase production, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used. Usage To reduce the development of drug–resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are combination of amoxicillin, a penicillin–class antibacterial and clavulanate potassium, a beta–lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta–lactamase production, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used.

( 1 ) Usage To reduce the development of drug–resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 mg or 875 mg every 12 hours or 250 mg or 500 mg every 8 hours, based on amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.

( 2.3 )

2.1Important Administration Instructions Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be taken at the start of a meal.

2.2Adult Patients See dosing regimens of amoxicillin/clavulanate potassium (based on the amoxicillin component) provided in Table 1 below. Table 1. Dosing Regimens of Amoxicillin/Clavulanate Potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN/CLAVULANATE POTASSIUM Severe infections and infections of the respiratory tract one 875 mg tablet a of amoxicillin/clavulanate potassium every 12 hours or one 500 mg tablet b,c of amoxicillin/clavulanate potassium every 8 hours Less severe infections one 500 mg tablet b,c of amoxicillin/clavulanate potassium every 12 hours or one 250 mg tablet d of amoxicillin/clavulanate potassium every 8 hours a Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL for oral suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspension may be used in place of the 875 mg/125 mg tablet. b Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL for oral suspension in place of the 500 mg/125 mg tablet. c Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration ( 2.6 )] . d Amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration ( 2.6 )] .

2.3Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows: Neonates and Infants Aged less than 12 Weeks (less than 3 Months) : See dosing regimens of amoxicillin/clavulanate potassium provided in Table 2 below. Table 2: Dosing Regimens of Amoxicillin and Clavulanate Potassium for Oral Suspension in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months) PATIENT POPULATION DOSING REGIMEN Amoxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL for Oral Suspension a Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours a Experience with the amoxicillin and clavulanate potassium for oral suspension 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended.

Patients Aged 12 Weeks (3 Months) and Older and Weighing Less than 40 kg : See dosing regimens provided in Table 3 below. The every 12 hour regimen is recommended as it is associated with significantly less… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium Tablets, USP 500 mg/125 mg: White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 875 mg/125 mg: White, capsule–shaped, biconvex, film–coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side.

Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium for Oral Suspension USP 200 mg/28.5 mg per 5 mL: White to off–white, orange–raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt). 400 mg/57 mg per 5 mL: White to off–white, orange–raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt).

Amoxicillin and Clavulanate Potassium Chewable Tablets, USP 200 mg/28.5 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. 400 mg/57 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other. Tablets: 500 mg/125 mg tablet and a scored 875 mg/125 mg tablet.

( 3 ) For Oral Suspension: 200 mg/28.5 mg per 5 mL, and 400 mg/57 mg per 5 mL ( 3 ) Chewable Tablets: 200 mg/28.5 mg, and 400 mg/57 mg ( 3 )

⛔ Contraindications 96 words ▾

4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens–Johnson syndrome) to amoxicillin/clavulanate potassium or to other beta–lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium. ( 4.2 )

4.1Serious Hypersensitivity Reactions Amoxicillin/clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin/clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) if a reaction occurs. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses.

( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable). If this occurs, discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.

Monitor liver function tests in patients with hepatic impairment. ( 5.4 ) Clostridioides difficile –associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.5 ) Patients with mononucleosis who receive amoxicillin/clavulanate potassium develop skin rash.

Avoid amoxicillin/clavulanate potassium use in these patients. ( 5.6 ) Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.7 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin/clavulanate potassium. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

If an allergic reaction occurs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be discontinued, and appropriate therapy instituted.

5.2Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) may cause severe cutaneous adverse reactions (SCAR), such as Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) discontinued if lesions progress.

5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), [see Adverse Reactions ( 6.2 )] , with most cases occurring in pediatric patients ≤18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms.

DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clav… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%) ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions.

The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (less than 1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin/clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin/clavulanate potassium for 10 days in the treatment of acute otitis media.

A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see Clinical Studies ( 14.2 )] .

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin/clavulanate potassium. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin/clavulanate potassium.

Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, Drug-induced enterocolitis syndrome (DIES), black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.5 )] . Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions ( 5.1 )].

Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis. Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin/clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.

The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic–hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Coadministration with probenecid is not recommended. ( 7.1 ) Concomitant use of amoxicillin/clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Coadministration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin/clavulanate potassium may reduce efficacy of oral contraceptives. ( 7.4 )

7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin/clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.

7.2Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin/clavulanate potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

7.3Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4Oral Contraceptives Amoxicillin/clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

7.5Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin/clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger. ( 8.4 ) Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30 mL/min). ( 2.4 , 8.6 )

8.1Pregnancy Teratogenic Effects : Reproduction studies performed in pregnant rats and mice given amoxicillin/clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin/clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).

There are, however, no adequate and well–controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.2Labor and Delivery Oral ampicillin-class antibacterials are poorly absorbed during labor. It is not known whether use of amoxicillin/clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) have been established in pediatric patients. Use of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [ see Clinical Studies ( 14.2 ) ].

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [ see Dosage and Administration ( 2.3 ) ].

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin/clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment [see Dosage and Administration ( 2.4 )] for specific recommendations in patients with renal impairment.

🤰 Pregnancy 126 words ▾

8.1Pregnancy Teratogenic Effects : Reproduction studies performed in pregnant rats and mice given amoxicillin/clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin/clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).

There are, however, no adequate and well–controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 162 words ▾

8.4Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) have been established in pediatric patients. Use of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [ see Clinical Studies ( 14.2 ) ].

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [ see Dosage and Administration ( 2.3 ) ].

🧓 Geriatric Use 136 words ▾

8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin/clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 153 words ▾

10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin/clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration.

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration ( 2.4 ) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are antibacterial drugs [see Microbiology ( 12.4 )] .

12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of amoxicillin and clavulanate potassium tablets are shown in Table 6 and following administration of amoxicillin and clavulanate potassium for oral suspension and tablets (chewable) are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen of Amoxicillin/Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin/Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500 mg/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 mg/125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875 mg/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ±

3.04Mean (± standard deviation) values of 14 normal adults (N equals 15 for clavulanate potassium in the low–dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose. Amoxicillin and clavulanate potassium administered at the start of a light meal.

Table 7: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets Dose of Amoxicillin/Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin/Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.10 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400 mg/57 mg (1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ±

0.73Mean ( ± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1 hour after the dose. Amoxicillin and clavulanate potassium administered at the start of a light meal.

Oral administration of 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*h/mL for amoxicillin and 2.9 mcg*h/mL for clavulanic acid when 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension or equivalent dose of 10 mL of the 125 mg/31.25 mg per 5 mL suspension of amoxicillin and clavulanate potassium were administered to normal adults.

One 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium tablets (chewable) or two 125 mg/31.25 mg chewable tablets of amoxicillin and clavulanate potassium tablets (chewable) are equivalent to 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin/clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone.

Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8–hour dosing regimens of amoxicillin/clavulanate potassium in adults and children. Absorption : Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin/clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 32 words ▾

12.1Mechanism of Action Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are antibacterial drugs [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and clavulanate potassium tablets, USP are supplied as follows: 500 mg/125 mg: White, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets (NDC 0093–2274–34).

875 mg/125 mg: White, capsule–shaped, biconvex, film–coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets (NDC 0093–2275–34).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Amoxicillin and clavulanate potassium for oral suspension, USP is supplied as follows: 200 mg/28.5 mg per 5 mL: White to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 200 mg amoxicillin, USP and 28.5 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2277–73).

400 mg/57 mg per 5 mL: White to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 400 mg amoxicillin, USP and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2279–73). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Amoxicillin and clavulanate potassium tablets, USP (chewable) are supplied as follows: 200 mg/28.5 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. They are available in bottles of 20 tablets (NDC 0093–2270–34). 400 mg/57 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other.

They are available in bottles of 20 tablets (NDC 0093–2272–34). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light–resistant container as defined in the USP, with a child–resistant closure (as required).

Keep this and all medications out of the reach of children.

📋 Description ~3 min read ▾

11 DESCRIPTION Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta–lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6–aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S , 5R , 6R )–6–[( R )–(–)–2–Amino–2–( p –hydroxyphenyl)acetamido]–3,3–dimethyl–7–oxo–4–thia–1–azabicyclo[3.2.0]heptane–2–carboxylic acid trihydrate and has the following structural formula: C 16 H 19 N 3 O 5 S•3H 2 O M.W.

419.45 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. Chemically, clavulanate potassium, USP is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula: C 8 H 8 KNO 5 M.W.

237.25 Amoxicillin and Clavulanate Potassium Tablets, USP: 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 200 mg/28.5 mg per 5 mL: Following reconstitution, each 5 mL of oral suspension contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium).

400 mg/28.5 mg per 5 mL: Following reconstitution, each 5 mL of oral suspension contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable): 200 mg/28.5 mg: Each chewable tablet contains 200 mg of amoxicillin, USP as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). 400 mg/57 mg: Each chewable tablet contains 400 mg of amoxicillin, USP as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium).

Inactive Ingredients: Amoxicillin and Clavulanate Potassium Tablets, USP - colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. Each tablet of amoxicillin and clavulanate potassium tablets, USP contains 0.63 mEq potassium. Amoxicillin and Clavulanate Potassium for Oral Suspension, USP - artificial raspberry powder, aspartame, citric acid, colloidal silicon dioxide, mannitol, hypromellose, natural orange flavor, sodium citrate, sodium saccharin and xanthan gum [see Warnings and Precautions ( 5.8 ] .

Each 5 mL of reconstituted 200 mg/28.5 mg oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 5 mL of reconstituted 400 mg/57 mg oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium Amoxicillin and Clavulanate Potassium Tablets, USP (Chewable) - aspartame, colloidal silicon dioxide, FD&C Red #40 lake, magnesium stearate, mannitol, microcrystalline cellulose, SA84 artificial ripe banana flavor, and artificial cherry flavor powder [see Warnings and Precautions ( 5.8 ] .

Each 200 mg/28.5 mg chewable tablet of amoxicillin and clavulanate potassium contains 0.14 mEq potassium Each 400 mg/57 mg chewable tablet of amoxicillin and clavulanate potassium contains 0.29 mEq potassium amoxicillin structural formula clavulanic acid structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients that amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset. Allergic Reactions Counsel patients that amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) contain a penicillin class drug product that can cause allergic reactions in some individuals.

Severe Cutaneous Adverse Reactions (SCAR ) Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions ( 5.2 )] . Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued.

Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) or other antibacterial drugs in the future.

Storage Instructions Advise patients to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin/clavulanate potassium, use a calibrated oral syringe.

Be sure to rinse the calibrated oral syringe after each use. Bottles of suspension of amoxicillin/clavulanate potassium may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.

Discard any unused medicine. Brands listed are the trademarks of their respective owners. Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

G 6/2024

🍼 Nursing Mothers 38 words ▾

8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of amoxicillin and clavulanate potassium tablets are shown in Table 6 and following administration of amoxicillin and clavulanate potassium for oral suspension and tablets (chewable) are shown in Table 7. Table 6: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets Dose and Regimen of Amoxicillin/Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin/Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.70 26.7 ± 4.56 12.6 ± 3.25 500 mg/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 mg/125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875 mg/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ±

3.04Mean (± standard deviation) values of 14 normal adults (N equals 15 for clavulanate potassium in the low–dose regimens). Peak concentrations occurred approximately 1.5 hours after the dose. Amoxicillin and clavulanate potassium administered at the start of a light meal.

Table 7: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets Dose of Amoxicillin/Clavulanate Potassium C max (mcg/mL) AUC 0-24 (mcg*h/mL) Amoxicillin/Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.10 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400 mg/57 mg (1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ±

0.73Mean ( ± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1 hour after the dose. Amoxicillin and clavulanate potassium administered at the start of a light meal.

Oral administration of 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*h/mL for amoxicillin and 2.9 mcg*h/mL for clavulanic acid when 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension or equivalent dose of 10 mL of the 125 mg/31.25 mg per 5 mL suspension of amoxicillin and clavulanate potassium were administered to normal adults.

One 250 mg/62.5 mg chewable tablet of amoxicillin and clavulanate potassium tablets (chewable) or two 125 mg/31.25 mg chewable tablets of amoxicillin and clavulanate potassium tablets (chewable) are equivalent to 5 mL of the 250 mg/62.5 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin/clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone.

Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8–hour dosing regimens of amoxicillin/clavulanate potassium in adults and children. Absorption : Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin/clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state.

In one study, the relative bioavailability of clavulanate was reduced when amoxicillin/clavulanate potassium was dosed at 30 and 150 minutes after the start of a high–fat breakfast. Distribution : Neither component in amoxicillin/clavulanate… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Lower Respiratory Tract and Complicated Urinary Tract Infections Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets every 12 hours to 500 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the every 12 hours and every 8 hours dosing regimens.

There was no significant difference in the percentage of adverse events in each group. The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875 mg every 12 hours and 500 mg every 8 hours dosing regimens (15% and 14%, respectively); however, there was a statistically significant difference (p less than 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1% for 875 mg every 12 hours regimen versus 2% for the 500 mg every 8 hours regimen. In one of these pivotal trials, patients with either pyelonephritis (n equals 361) or a complicated urinary tract infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria following eradication, n equals 268) were randomized (1:1) to receive either 875 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets every 12 hours (n equals 308) or 500 mg/125 mg tablets of amoxicillin and clavulanate potassium tablets every 8 hours (n equals 321).

The number of bacteriologically evaluable patients was comparable between the two dosing regimens. Amoxicillin and clavulanate potassium tablets produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at one of the follow–up visits (5 to 9 days post–therapy) and at a late post–therapy visit (in the majority of cases, this was 2 to 4 weeks post–therapy), as seen in Table 8.

Table 8: Bacteriologic Efficacy Rates for Amoxicillin and Clavulanate Potassium Tablets Time Post Therapy 875 mg every 12 hours % (n) 500 mg every 8 hours % (n) 2 to 4 days 81% (58) 80% (54) 5 to 9 days 58% (41) 52% (52) 2 to 4 weeks 52% (101) 55% (104) As noted, before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.

14.2Acute Bacterial Otitis Media and Diarrhea in Pediatric Patients One U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days in the treatment of acute otitis media. Only the suspension formulations were used in this trial. A total of 575 pediatric patients (aged 2 months to 12 years) were enrolled, with an even distribution among the 2 treatment groups and a comparable number of patients were evaluable (i.e., greater than or equal to 84%) per treatment group.

Otitis media–specific criteria were required for eligibility and a strong correlation was found at the end of therapy and follow–up between these criteria and physician assessment of clinical response. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow–up visit (defined as 22 to 28 days post–completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n equals 265) and 82% (n equals 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

At follow–up, 67% (n equals 249) and 69% (n equals 243) for 45 mg/kg/day every… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 214 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin/clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin/clavulanate potassium was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.

Amoxicillin/clavulanate potassium was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays. Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 211 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin/clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin/clavulanate potassium was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.

Amoxicillin/clavulanate potassium was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test and was negative in each of these assays. Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats.

Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

📚 References 31 words ▾

15 REFERENCES Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.

📄 Recent Major Changes 18 words ▾

Warnings and Precautions ( 5 ) 8/2022 Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) ( 5.3 ) 05/2024

📄 Package Label / Principal Display Panel 142 words ▾

Package/Label Display Panel NDC 0093-2274-34 Amoxicillin and Clavulanate Potassium Tablets, USP 500 mg/125 mg* Rx only 20 TABLETS image

Package/Label Display Panel NDC 0093-2275-34 Amoxicillin and Clavulanate Potassium Tablets, USP 875 mg/125 mg* Rx only 20 TABLETS image

Package/Label Display Panel NDC 0093-2277-73 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL* *When reconstituted, each 5 mL contains: AMOXICILLIN, USP 200 mg as the trihydrate, and CLAVULANIC ACID, 28.5 mg (equivalent to 34 mg of clavulanate potassium, USP) Rx only 100 mL (when reconstituted) image

Package/Label Display Panel NDC 0093-2279-73 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL* *When reconstituted, each 5 mL contains: AMOXICILLIN, USP 400 mg as the trihydrate, and CLAVULANIC ACID, 57 mg (equivalent to 68 mg of clavulanate potassium, USP) Rx only 100 mL (when reconstituted) image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
43
Units reimbursed last 4 qtrs
4.6K
Gross reimbursed last 4 qtrs
$685.35
Avg / prescription
$15.94
Avg / unit
$0.1506
Latest quarter Q1 2026
25Rx
Medicaid pays / mL
$0.1506
gross reimbursed
vs
NADAC / mL
$0.0481
acquisition cost
=
Spread
+$0.1025
+213% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 43 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 4,550 units · 23.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
23.223.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 23.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 00093-2275-34 · Teva 00093-2279-73 · Teva →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.