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Amoxicillin 500 mg Capsule, 15-count — NDC 43063-0820-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amoxicillin 500 mg Capsule, 15-count — NDC 43063-820-15 (Billing 43063-0820-15)

by PD-Rx Pharmaceuticals, Inc. · 15 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 15 capsules of Amoxicillin 500 mg Capsule from PD-Rx Pharmaceuticals, Inc., marketed since Nov 2005 and currently FDA-listed.

NDC 43063-0820-15
🏷️ FDA NDC (as labeled) 43063-820-15 billing pads the product segment with a zero
This package
Contains15-count Pack sizes12 compare ↓
Also priced by: Part D plans $0.1924/unit — full pricing hub ↓
Product page 43063-0820-04 Also comes in: 4 capsules 43063-820-04 6 capsules 43063-820-06 8 capsules 43063-820-08 14 capsules 43063-820-14 20 capsules 43063-820-20 21 capsules 43063-820-21 28 capsules 43063-820-28 30 capsules 43063-820-30 40 capsules 43063-820-40 50 capsules 43063-820-50 56 capsules 43063-820-56
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 43063-820-15
Product NDC 43063-820
11-digit billing NDC 43063082015
NCPDP billing unit EA — each (per item)
RxCUI 308191
UNII 804826J2HU
UPC 0343063820308
Application # ANDA065271
SPL Set ID d0938df9-9065-47eb-9eae-0722ed1411a1
Established class (EPC) Penicillin-class Antibacterial
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-11-09
Route ORAL
Dosage form CAPSULE
Substance AMOXICILLIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 01200010100110
GPI class Amoxicillin
GCN Seq No 008996
GCN 39661
HICL code 003963
Ingredient (HICL) Amoxicillin
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 AMOXICILLIN 500 MG CAPSULE
FDB brand name Amoxicillin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008996
  • GCN: 39661
  • GPI-14 (Medi-Span): 01200010100110
  • HICL (First Databank): 003963
  • AHFS class code: 08:12.16.08
  • RxCUI (RxNorm): 308191
Why two NDCs? The FDA registers this code as 43063-820-15 — a 5-3-2 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 product segment → 43063-0820-15. 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 Penicillin-class Antibacterial class.

Pharmacologic class Penicillin-class Antibacterial
Drug family (ATC) Penicillins with extended spectrum
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 AMOXICILLIN 500 MG CAPSULE Ingredient Amoxicillin
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for infections caused by susceptible bacteria. These include ear, nose and throat, chest, urinary tract and skin infections. In adults it is also used with othe...
  • Take it by mouth at the start of a meal, which helps limit stomach upset. Follow the schedule your prescriber gave you. Finish the full course even if you feel better, because stop...
  • Diarrhea, nausea, vomiting and mild rash are the most common. Call your doctor if a rash spreads, if you have severe or bloody diarrhea, or if your child has repeated vomiting an h...
  • What side effects are normal, and when should I call?
📖 Read our full Amoxicillin guide →
8
Nutrient depletion considerations

Amoxicillin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Amoxicillin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1924 $2.89 / 15 capsules
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
43063-0820-04 43063-820-04 Main listing 4 CAPSULE in 1 BOTTLE, PLASTIC 2019-03-01 — Active
43063-0820-06 43063-820-06 6 CAPSULE in 1 BOTTLE, PLASTIC 2018-03-09 — Active
43063-0820-08 43063-820-08 8 CAPSULE in 1 BOTTLE, PLASTIC 2018-09-12 — Active
43063-0820-14 43063-820-14 14 CAPSULE in 1 BOTTLE, PLASTIC 2018-05-18 — Active
43063-0820-15 You're viewing this 15 CAPSULE in 1 BOTTLE, PLASTIC 2017-01-05 — Active
43063-0820-20 43063-820-20 20 CAPSULE in 1 BOTTLE, PLASTIC 2020-12-02 — Active
43063-0820-21 43063-820-21 21 CAPSULE in 1 BOTTLE, PLASTIC 2018-02-15 — Active
43063-0820-28 43063-820-28 28 CAPSULE in 1 BOTTLE, PLASTIC 2018-02-26 — Active
43063-0820-30 43063-820-30 30 CAPSULE in 1 BOTTLE, PLASTIC 2018-04-03 — Active
43063-0820-40 43063-820-40 40 CAPSULE in 1 BOTTLE, PLASTIC 2018-04-03 — Active
43063-0820-50 43063-820-50 50 CAPSULE in 1 BOTTLE, PLASTIC 2021-07-06 — Active
43063-0820-56 43063-820-56 56 CAPSULE in 1 BOTTLE, PLASTIC 2018-02-26 — Active

You're viewing one of 12 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 15-count package — 15 capsule in 1 bottle, plastic.
How does this package differ from NDC 43063-0820-04?
Both are Amoxicillin 500 mg Capsule — the drug itself is identical. This page's package is the 15-count one, while NDC 43063-0820-04 is the 4 capsules package.
What NDC number is used to bill for this package of Amoxicillin 500 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amoxicillin 500 mg 00093-3109-05 Teva 500 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 00143-9939-05 Hikma 500 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 00781-2613-01 Sandoz 100 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 42571-0234-01 Micro 100 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 57237-0031-01 Rising 100 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 60687-0787-01 American 100 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 65862-0017-01 Aurobindo 100 capsules $0.079 — Availability likely —
Amoxicillin 500 mg 81964-0205-01 USAntibiotics, 100 capsules $0.079 AB Availability likely —
Amoxicillin 500 mg 16714-0299-01 NorthStar 30 capsules — AB FDA listed —
Amoxicillin 500 mg 42708-0010-30 QPharma, 30 capsules — AB FDA listed —
Amoxicillin 500 mg 42708-0076-30 QPharma 30 capsules — AB FDA listed —
Amoxicillin 500 mg 42708-0153-30 QPharma 30 capsules — AB FDA listed —
Amoxicillin 500 mgthis 43063-0820-15 PD-Rx 15 capsules — AB FDA listed —
Amoxicillin 500 mg 43063-0915-30 PD-Rx 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-0301-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-0302-00 A-S 12 capsules — AB Discontinued —
Amoxicillin 500 mg 50090-0303-00 A-S 14 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-0304-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1511-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1512-00 A-S 12 capsules — AB Discontinued —
Amoxicillin 500 mg 50090-1513-00 A-S 14 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1514-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1794-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1795-04 A-S 56 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1796-00 A-S 14 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1797-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1810-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1811-04 A-S 56 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1812-00 A-S 14 capsules — AB FDA listed —
Amoxicillin 500 mg 50090-1813-00 A-S 30 capsules — AB FDA listed —
Amoxicillin 500 mg 51655-0156-20 Northwind 20 capsules — AB Discontinued —
Amoxicillin 500 mg 62135-0825-05 Chartwell 500 capsules — AB FDA listed —
Amoxicillin 500 mg 63187-0399-10 Proficient 10 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-5730-01 Bryant 15 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-5738-01 Bryant 20 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-5739-01 Bryant 21 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7584-01 Bryant 30 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7585-01 Bryant 21 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7587-01 Bryant 20 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7798-01 Bryant 15 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7801-01 Bryant 40 capsules — AB FDA listed —
Amoxicillin 500 mg 63629-7802-01 Bryant 21 capsules — AB FDA listed —
Amoxicillin 500 mg 67046-0316-03 Coupler 30 capsules — AB FDA listed —
Amoxicillin 500 mg 67046-1175-03 Coupler 30 capsules — AB FDA listed —
Amoxicillin 500 mg 67296-1914-03 Redpharm 30 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-3119-01 NuCare 21 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-3517-01 NuCare 21 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-3574-01 NuCare 100 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-3662-03 NuCare 3 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4455-00 NuCare 10 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4468-01 NuCare 21 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4548-03 NuCare 3 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4574-03 NuCare 3 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4698-03 NuCare 3 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4724-01 NuCare 100 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4907-01 NuCare 21 capsules — AB FDA listed —
Amoxicillin 500 mg 68071-4920-01 NuCare 100 capsules — AB FDA listed —
Amoxicillin 500 mg 68788-8209-02 Preferred 21 capsules — AB FDA listed —
Amoxicillin 500 mg 68999-0825-01 Chartwell 100 capsules — AB FDA listed —
Amoxicillin 500 mg 70518-0895-01 REMEDYREPACK 100 capsules — AB Discontinued —
Amoxicillin 500 mg 70518-2190-00 REMEDYREPACK 28 capsules — AB FDA listed —
Amoxicillin 500 mg 70518-3294-01 REMEDYREPACK 100 capsules — AB FDA listed —
Amoxicillin 500 mg 70518-3832-00 REMEDYREPACK 40 capsules — AB Discontinued —
Amoxicillin 500 mg 70518-3914-00 REMEDYREPACK 100 capsules — AB Discontinued —
Amoxicillin 500 mg 70518-4279-00 REMEDYREPACK 100 capsules — AB FDA listed —
Amoxicillin 500 mg 70518-4371-00 REMEDYREPACK 30 capsules — AB FDA listed —
Amoxicillin 500 mg 70882-0114-20 Cambridge 20 capsules — AB Discontinued —
Amoxicillin 500 mg 71205-0507-14 Proficient 14 capsules — AB FDA listed —
Amoxicillin 500 mg 71205-0817-14 Proficient 14 capsules — AB FDA listed —
Amoxicillin 500 mg 72789-0225-82 PD-Rx 500 capsules — AB FDA listed —
Amoxicillin 500 mg 72789-0254-30 PD-Rx 30 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0112-30 Asclemed 30 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0192-21 Asclemed 21 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0508-50 Asclemed 50 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0545-50 Asclemed 50 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0833-01 Asclemed 100 capsules — AB FDA listed —
Amoxicillin 500 mg 76420-0871-03 Asclemed 21 capsules — AB FDA listed —
Amoxicillin 500 mg 80425-0269-01 Advanced 28 capsules — AB FDA listed —
Amoxicillin 500 mg 81964-0350-10 USAntibiotics, 100 capsules — AB FDA listed —
Amoxicillin 500 mg 82868-0056-14 Northwind 14 capsules — AB FDA listed —
Amoxicillin 500 mg 82982-0022-20 Pharmasource 20 capsules — AB Discontinued —
Amoxicillin 500 mg 83112-0500-21 Health 21 capsules — AB FDA listed —
Amoxicillin 500 mg 85766-0021-21 Sportpharm 21 capsules — AB FDA listed —
Amoxicillin 500 mg 85766-0185-00 Sportpharm 100 capsules — AB FDA listed —
Amoxicillin 500 mg 85534-0040-00 HAWAII 20 capsules — AB FDA listed —
Amoxicillin 500 mg 62135-0083-01 Chartwell 100 capsules — AB Discontinued —
Amoxicillin 500 mg 67296-2292-02 Redpharm 20 capsules — AB FDA listed —
Amoxicillin 500 mg 68999-0083-01 Chartwell 100 capsules — AB FDA listed —
Amoxicillin 500 mg 85766-0267-10 Sportpharm 10 capsules — 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
Nov 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 blue / pink
ShapeCapsule
ImprintA45
Size23 mm
ScoringNot scored
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 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

8 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

LabelerPD-Rx Pharmaceuticals, Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA065271 (ANDA)
Labeler code43063
First marketedNov 2005
Product typeHuman Prescription Drug
Portfolio834 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 Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .

Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Infections of the Lower Respiratory Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp.

(α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole : Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual therapy for H. pylori with lansoprazole : Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by 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 capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 ) Adults and Pediatric Patients ( 1 ) Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 ) Helicobacter pylori Infection and Duodenal Ulcer Disease Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules 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 In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens.

( 2.2 , 2.3 ) The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3 ) Dosing for H. pylori Infection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

( 2.4 ) Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). (2.5)

2.1Important Administration Instructions To minimize the potential for gastrointestinal intolerance, amoxicillin capsules should be taken at the start of a meal.

2.2Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks.

It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older Infection Severity a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Recommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.

2.3Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months) It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.

2.4Dosage for H. pylori Infection in Adults Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.

2.5Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration r… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS 250 mg Capsule are blue/pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink. 500 mg Capsule are blue/pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink. Capsules: 250 mg and 500 mg (3)

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS Amoxicillin capsules are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin capsules or to other beta-lactams (e.g., penicillins or cephalosporins). (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue amoxicillin 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 amoxicillin use. If this occurs, discontinue amoxicillin and institute appropriate therapy.

( 5.3 ) Clostridioides difficile -associated diarrhea (CDAD) (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.4 )

5.1Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued, and appropriate therapy instituted.

5.2Severe Cutaneous Adverse Reactions Amoxicillin 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 skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress.

5.3Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use [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 maybeassociated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia.

If DIES occurs, discontinue amoxicillin and institute appropriate therapy.

5.4Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.5Development of Drug-Resistant Bacteria Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug… [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) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or for oral suspension were diarrhea, rash, vomiting, and nausea.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials 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 common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy : The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

Dual therapy: The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.

6.2Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. 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.

Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.4) ] .

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: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown.

Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported [see Overdosage (10 )] . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported.

These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, aseptic meningitis, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported.

Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Co-administration with probenicid is not recommended. ( 7.1 ) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 )

7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

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. 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 rashes is due to allopurinol or the hyperuricemia present in these patients.

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

7.5Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented.

7.6Effects on Laboratory Tests High urine concentrations of ampicillin 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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or 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 ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin.

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

8.2Labor and Delivery Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin 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 Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H.Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.

Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3) ].

8.5Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a 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 toxic 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.

8.6Dosing in Renal 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 Dosing in Renal Impairment (2.5) for specific recommendations in patients with renal impairment.

🤰 Pregnancy 80 words ▾

8.1Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin.

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

🧒 Pediatric Use 97 words ▾

8.4Pediatric Use The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H.Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.

Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3) ].

🧓 Geriatric Use 107 words ▾

8.5Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a 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 toxic 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 144 words ▾

10 OVERDOSAGE In case of overdosage, discontinue amoxicillin, 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. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1 .

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin 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. Amoxicillin may be removed from circulation by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amoxicillin is an antibacterial drug [see Microbiology (12.4) ].

12.3Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.

Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin with 875 mg of amoxicillin and clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg●hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.

Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 4: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose* Amoxicillin AUC 0- ∞ (mcg●hr/mL) Amoxicillin (±S.D.) C max (mcg/mL) † Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) * Administered at the start of a light meal. † Mean values of 24 normal volunteers.

Peak concentrations occurred approximately 1 hour after the dose. Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound.

Following a 1 gram dose, and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours.

Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] .

12.4Microbiology Mechanism of Action Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Resistance Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive.

Antimicrobial Activity Amoxicillin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ]. Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp.

(alpha and beta-hemolytic) Gram-Negative Bacteria Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Susceptibility Testing : For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action Amoxicillin is an antibacterial drug [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin Capsules, USP contains 500 mg amoxicillin USP as the trihydrate. 500 mg Capsule Blue/Pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink. Bottles of 4 NDC 43063-820-04 Bottles of 6 NDC 43063-820-06 Bottles of 8 NDC 43063-820-08 Bottles of 14 NDC 43063-820-14 Bottles of 15 NDC 43063-820-15 Bottles of 20 NDC 43063-820-20 Bottles of 21 NDC 43063-820-21 Bottles of 28 NDC 43063-820-28 Bottles of 30 NDC 43063-820-30 Bottles of 40 NDC 43063-820-40 Bottles of 50 NDC 43063-820-50 Bottles of 56 NDC 43063-820-56 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

📋 Description 151 words ▾

11 DESCRIPTION Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S ,5 R ,6 R )-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. It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.45.

Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink.

Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No.

40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2. str

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Allergic Reactions Counsel patients that amoxicillin contains 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 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 antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, 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 drug.

If this occurs, patients should contact their physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat or prevent bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold).

When amoxicillin is 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 or other antibacterial drugs in the future. CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation. CLOtest is a registered trademark of Kimberly-Clark Corporation. Distributed by: Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2024

🍼 Nursing Mothers 36 words ▾

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

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.

Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin with 875 mg of amoxicillin and clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg●hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.

Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 4: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose* Amoxicillin AUC 0- ∞ (mcg●hr/mL) Amoxicillin (±S.D.) C max (mcg/mL) † Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) * Administered at the start of a light meal. † Mean values of 24 normal volunteers.

Peak concentrations occurred approximately 1 hour after the dose. Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound.

Following a 1 gram dose, and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours.

Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] .

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily ( see Table 5 ).

Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily ( see Table 6 ). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Table 5. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 [80 to 97.7] (n equals 48) 86 [73.3 to 93.5] (n equals 55) Study 2 86 [75.7 to 93.6] (n equals 66) 83 [72 to 90.8] (n equals 70) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture.

Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.

Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 to 87.2] (n equals 51) 70 [56.8 to 81.2] (n equals 60) Study 2 66 [51.9 to 77.5] (n equals 58) 61 [48.5 to 72.9] (n equals 67) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture.

Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.

🧪 Nonclinical Toxicology 182 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay.

Amoxicillin and potassium clavulanate 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 and potassium clavulanate 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.

In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 179 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay.

Amoxicillin and potassium clavulanate 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 and potassium clavulanate 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.

In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

📚 References 32 words ▾

15 REFERENCES 1. 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 11 words ▾

Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) ( 5.3 ) 01/2024

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg Rx only Amoxicillin Capsules, USP 500 mg AMOXICILLIN, 500 mg as the trihydrate 43063820 LABEL

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Amoxicillin — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Amoxicillin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$9.35M
Claims incl. refills
2.5M
Beneficiaries
2.1M
Spend / beneficiary
$4.38
Spend / claim
$3.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PD-Rx Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 11 other package presentations of this same product, including 4 capsules (43063-0820-04), 6 capsules (43063-0820-06), 8 capsules (43063-0820-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
PD-Rx Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43063-0815-01 · PD-Rx 43063-0821-30 · PD-Rx →
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.