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Cephalexin 500 mg Capsule, 15-count — NDC 63187-0046-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cephalexin 500 mg Capsule, 15-count — NDC 63187-046-15 (Billing 63187-0046-15)

by Proficient Rx LP · 15 CAPSULE in 1 BOTTLE (63187-046-15)

NDC 63187-046-15 (billing 63187-0046-15) is a package of 15 capsules of Cephalexin 500 mg Capsule from Proficient Rx LP, marketed since Jan 2006 and currently FDA-listed.

NDC 63187-0046-15
🏷️ FDA NDC (as labeled) 63187-046-15 billing pads the product segment with a zero
This package
Contains15-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.1952/unit — full pricing hub ↓
Product page 63187-0046-06 Also comes in: 6 capsules 63187-046-06 14 capsules 63187-046-14 20 capsules 63187-046-20 21 capsules 63187-046-21 28 capsules 63187-046-28 30 capsules 63187-046-30 40 capsules 63187-046-40
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

⚠️
Other active recalls for Cephalexin (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0469-2025
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0468-2025
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g (Bryant Ranch Prepack, Inc.) · FDA recall D-0537-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0539-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0538-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0540-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-046-15
Product NDC 63187-046
11-digit billing NDC 63187004615
NCPDP billing unit EA — each (per item)
RxCUI 309114
UNII OBN7UDS42Y
UPC 0363187046286
Application # ANDA065229
SPL Set ID dec3a1ef-1e85-4236-804b-e7a343d3a58f
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-01-11
Route ORAL
Dosage form CAPSULE
Substance CEPHALEXIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 02100020000110
GPI class Cephalexin
GCN Seq No 009043
GCN 39802
HICL code 013908
Ingredient (HICL) Cephalexin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1W
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 1St Generation
AHFS code 08:12.06.04
AHFS class 1St Generation Cephalosporin Antibiotics
FDB label name CEPHALEXIN 500 MG CAPSULE
FDB brand name Cephalexin
Legend status F — Federal legend — prescription drug or device
Quick answers for NDC 63187-046-15
  • GSN (GCN sequence number): 009043
  • GCN: 39802
  • GPI-14 (Medi-Span): 02100020000110
  • HICL (First Databank): 013908
  • AHFS class code: 08:12.06.04
  • RxCUI (RxNorm): 309114
  • 11-digit billing NDC: 63187004615
Why two NDCs? The FDA registers this code as 63187-046-15 — 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 → 63187-0046-15. 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 Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) First-generation cephalosporins
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 CEPHALEXIN 500 MG CAPSULE Ingredient Cephalexin
📖 What it is MedlinePlus · NLM

Cephalexin is used to treat certain infections caused by bacteria. Cephalexin is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cephalexin 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 antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cephalexin is an antibiotic used to treat bacterial infections — things like strep throat and other respiratory infections, ear infections, skin infections, bone infections, and ur...
  • Yes, you can take cephalexin with or without food — it's stable in stomach acid either way. If it upsets your stomach, taking it with a small meal or snack can help. Just try to ta...
  • The most common side effects are stomach-related — diarrhea, nausea, vomiting, or indigestion. These are usually mild and manageable. The ones to call your doctor about are: a seve...
  • What side effects should I watch out for?
📖 Read our full Cephalexin guide →
7
Nutrient depletion considerations

Cephalexin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cephalexin 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 $0.1952 $2.93 / 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
63187-0046-06 63187-046-06 Main listing 6 CAPSULE in 1 BOTTLE (63187-046-06) 2018-04-02 — Active
63187-0046-14 63187-046-14 14 CAPSULE in 1 BOTTLE (63187-046-14) 2018-10-01 — Active
63187-0046-15 63187-046-15 You're viewing this 15 CAPSULE in 1 BOTTLE (63187-046-15) 2019-03-01 — Active
63187-0046-20 63187-046-20 20 CAPSULE in 1 BOTTLE (63187-046-20) 2014-04-01 — Active
63187-0046-21 63187-046-21 21 CAPSULE in 1 BOTTLE (63187-046-21) 2014-04-01 — Active
63187-0046-28 63187-046-28 28 CAPSULE in 1 BOTTLE (63187-046-28) 2018-01-01 — Active
63187-0046-30 63187-046-30 30 CAPSULE in 1 BOTTLE (63187-046-30) 2014-04-01 — Active
63187-0046-40 63187-046-40 40 CAPSULE in 1 BOTTLE (63187-046-40) 2014-04-01 — Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0046-15?
NDC 63187-0046-15 is a 15-count package — 15 capsule in 1 bottle.
What is the difference between NDC 63187-0046-15 and NDC 63187-0046-06?
Both are Cephalexin 500 mg Capsule — the drug itself is identical. NDC 63187-0046-15 is the 15-count package, while NDC 63187-0046-06 is the 6 capsules package.
What NDC number is used to bill for this package of Cephalexin 500 mg Capsule?
Bill NDC 63187-0046-15 — the 11-digit billing format is 63187004615. 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
Cephalexin 500 mg 00093-3147-01 Teva 100 capsules $0.120 AB Discontinued —
Cephalexin 500 mg 00904-7337-06 Major 50 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 50268-0152-15 AvPAK 50 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 60687-0163-01 American 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 62135-0711-74 Chartwell 40 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 65862-0019-01 Aurobindo 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 67877-0219-01 Ascend 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 68180-0122-01 Lupin 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 42291-0007-50 AVKARE 500 capsules — AB FDA listed —
Cephalexin 500 mg 42708-0017-28 QPharma 28 capsules — AB FDA listed —
Cephalexin 500 mg 42708-0070-28 QPharma 28 capsules — AB FDA listed —
Cephalexin 500 mg 43063-0536-04 PD-Rx 4 capsules — AB FDA listed —
Cephalexin 500 mg 43063-0634-40 PD-Rx 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0079-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0080-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0081-00 A-S 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3199-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3252-00 A-S 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3427-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-4422-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-5948-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7026-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7027-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7162-01 A-S 28 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7223-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7224-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 51655-0028-20 Northwind 20 capsules — AB Discontinued —
Cephalexin 500 mg 55289-0058-04 PD-Rx 4 capsules — AB FDA listed —
Cephalexin 500 mg 61919-0606-20 Direct_Rx 20 capsules — AB FDA listed —
Cephalexin 500 mgthis 63187-0046-15 Proficient 15 capsules — AB FDA listed —
Cephalexin 500 mg 63629-4219-01 Bryant 40 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5740-01 Bryant 20 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5741-01 Bryant 28 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5742-01 Bryant 30 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7740-01 Bryant 28 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7742-01 Bryant 20 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7743-01 Bryant 14 capsules — AB FDA listed —
Cephalexin 500 mg 63629-8184-01 Bryant 12 capsules — AB FDA listed —
Cephalexin 500 mg 63629-8856-01 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 63629-9200-01 Bryant 100 capsules — AB FDA listed —
Cephalexin 500 mg 63629-9201-01 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 67046-1245-03 Coupler 30 capsules — AB FDA listed —
Cephalexin 500 mg 68071-2249-03 NuCare 30 capsules — AB FDA listed —
Cephalexin 500 mg 68071-3532-01 NuCare 21 capsules — AB FDA listed —
Cephalexin 500 mg 68071-3538-06 NuCare 6 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4355-01 NuCare 21 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4406-04 NuCare 14 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4429-03 NuCare 3 capsules — AB FDA listed —
Cephalexin 500 mg 68788-8538-01 Preferred 12 capsules — AB FDA listed —
Cephalexin 500 mg 68788-8740-01 Preferred 12 capsules — AB FDA listed —
Cephalexin 500 mg 69043-0009-01 Cronus 100 capsules — AB FDA listed —
Cephalexin 500 mg 69778-0931-04 Pharma-C, 500 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3059-00 REMEDYREPACK 14 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3066-00 REMEDYREPACK 30 capsules — AB Discontinued —
Cephalexin 500 mg 70518-3362-00 REMEDYREPACK 30 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3378-00 REMEDYREPACK 40 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3448-00 REMEDYREPACK 100 capsules — AB Discontinued —
Cephalexin 500 mg 70518-3857-00 REMEDYREPACK 42 capsules — AB Discontinued —
Cephalexin 500 mg 71205-0591-06 Proficient 6 capsules — AB FDA listed —
Cephalexin 500 mg 71205-0672-06 Proficient 6 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2685-01 Bryant 14 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2704-01 Bryant 21 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2976-01 Bryant 12 capsules — AB FDA listed —
Cephalexin 500 mg 72162-1830-01 Bryant 100 capsules — AB FDA listed —
Cephalexin 500 mg 72162-2145-05 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 72287-0310-01 AMELLA 100 capsules — AB FDA listed —
Cephalexin 500 mg 72789-0251-82 PD-Rx 500 capsules — AB FDA listed —
Cephalexin 500 mg 73614-0202-03 Brisk 30 capsules — AB Discontinued —
Cephalexin 500 mg 76420-0052-28 Asclemed 28 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0288-01 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0592-10 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0736-00 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0831-10 Asclemed 10 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0004-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0005-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0006-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0121-01 Advanced 28 capsules — AB FDA listed —
Cephalexin 500 mg 82804-0106-14 Proficient 14 capsules — AB FDA listed —
Cephalexin 500 mg 82868-0057-10 Northwind 10 capsules — AB FDA listed —
Cephalexin 500 mg 82868-0095-10 Northwind 10 capsules — AB FDA listed —
Cephalexin 500 mg 82982-0024-20 Pharmasource 20 capsules — AB Discontinued —
Cephalexin 500 mg 85766-0004-14 Sportpharm 14 capsules — AB FDA listed —
Cephalexin 500 mg 85766-0191-14 Sportpharm 14 capsules — AB FDA listed —
Cephalexin 500 mg 87441-0004-01 Unit 30 capsules — AB FDA listed —
Cephalexin 500 mg 85534-0078-00 HAWAII 1 capsule — AB FDA listed —
Cephalexin 500 mg 42291-0209-50 AvKARE 500 capsules — AB FDA listed —
Cephalexin 500 mg 68788-4143-01 Preferred 12 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

🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 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 Green
ShapeCapsule
Imprint500;LUPIN
Size22 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

12 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

LabelerProficient Rx LP
Application holderLUPIN LTD
FDA applicationANDA065229 (ANDA)
Labeler code63187
First marketedJan 2006
Product typeHuman Prescription Drug
Portfolio1,729 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes . (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis .

Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes . Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis . Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli , Proteus mirabilis , and Klebsiella pneumoniae.

Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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.

⏱️ Dosage and Administration 207 words ▾

DOSAGE AND ADMINISTRATION Cephalexin is administered orally. Adults: The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours.

For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed.

If daily doses of Cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered. Pediatric Patients: The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

In severe infections, the dosage may be doubled. In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required. In the treatment of ß-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

⚠️ Warnings ~1 min read ▾

WARNINGS BEFORE THERAPY WITH CEPHALEXIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALEXIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO CEPHALEXIN OCCURS, DISCONTINUE THE DRUG.

SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.

Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously. No exception should be made with regard to cephalexin. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, 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 antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Gastrointestinal: Onset of pseudomembranous colitis may occur during or after antibacterial treatment. (See WARNINGS ) Nausea and vomiting have been reported rarely. The most frequent side effect has been diarrhea.

It was very rarely severe enough to warrant cessation of therapy. Dyspepsia, gastritis, and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.

Hypersensitivity: Allergic reactions in the form of rash, urticaria, angioedema, and, rarely, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been observed. These reactions usually subsided upon discontinuation of the drug. In some of these reactions, supportive therapy may be necessary.

Anaphylaxis has also been reported. Other reactions have included genital and anal pruritus, genital moniliasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported rarely.

Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia and slight elevations in AST and ALT have been reported. In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: Adverse Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see INDICATIONS AND USAGE and PRECAUTIONS, General ).

If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Altered Laboratory Tests: Prolonged prothrombin time, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, pancytopenia, leukopenia, and agranulocytosis.

🔄 Drug Interactions 118 words ▾

Drug Interactions: Metformin: In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean C max and AUC increased by an average of 34 % and 24 %, respectively, and metformin mean renal clearance decreased by 14 %. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug. Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems.

Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin. Probenicid: As with other ß-lactams, the renal excretion of cephalexin is inhibited by probenecid.

🔄 Drug / Laboratory Test Interactions 37 words ▾

Drug / Laboratory Test Interactions: As a result of administration of cephalexin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions and also with Clinitest ® tablets.

🤰 Pregnancy 78 words ▾

Pregnancy: Teratogenic Effects- Pregnancy Category B: Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon mg/m 2 , and have revealed no harm to the fetus. 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 56 words ▾

Pediatric Use: The safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the DOSAGE AND ADMINISTRATION section. In these trials, pediatric patients may have received cephalexin capsules or cephalexin for oral suspension. Cephalexin capsules should only be used in children and adolescents capable of ingesting the capsule.

🧓 Geriatric Use 124 words ▾

Geriatric Use: Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62 %) were 65 and over. 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 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 (see PRECAUTIONS , General )

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Signs and Symptoms: Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. If other symptoms are present, it is probably secondary to an underlying disease state, an allergic reaction, or toxicity due to ingestion of a second medication. Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center.

Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference ( PDR ). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Unless 5 to 10 times the normal dose of cephalexin has been ingested, gastrointestinal decontamination should not be necessary.

Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.

Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been stablished as beneficial for an overdose of cephalexin; however, it would be extremely unlikely that one of these procedures would be indicated.

The oral median lethal dose of cephalexin in rats is >5,000 mg/kg.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Human Pharmacology: Cephalexin is acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL respectively were obtained at 1 hour.

Measurable levels were present 6 hours after administration. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours.

During this period, peak urine concentrations following the 250-mg, 500-mg, and 1-g doses were approximately 1000, 2200, and 5000 mcg/mL respectively. Microbiology: In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cephalexin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobes, Gram-Positive: Staphylococcus aureus (including penicillinase-producing strains) Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Aerobes, Gram-Negative: Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella (Branhamella) catarrhalis Proteus mirabilis Note - Methicillin-resistant staphylococci and most strains of enterococci ( Enterococcus faecalis [formerly Streptococcus faecalis ]) are resistant to cephalosporins, including cephalexin. It is not active against most strains of Enterobacter spp., Morganella morganii , and Proteus vulgaris .

It has no activity against Pseudomonas spp. or Acinetobacter calcoaceticus . Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics. Susceptibility Tests: Dilution Techniques: Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MIC's).

These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method 1-3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cephalothin powder.

The MIC values should be interpreted according to the following criteria: MIC (mcg /mL) Interpretation ≤8 Susceptible (S) 16 Intermediate (I) ≥32 Resistant (R) A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated.

This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard cephalothin powder should provide the following MIC values: Microorganism MIC (mcg /mL) E. coli ATCC 25922 4-16 S. aureus ATCC 29213 0.12-0.5 Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure 2,3 requires the use of standardized inoculum concentrations.

This procedure uses paper disks impregnated with 30- mcg cephalothin… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 117 words ▾

HOW SUPPLIED Cephalexin capsules USP 250 mg, 500 mg (or cephalexin, USP), are available in: 500 mg The 500 mg capsules are a white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light green body in edible black ink. They are available as follows: Bottles of 6 NDC 63187-046-06 Bottles of 14 NDC 63187-046-14 Bottles of 15 NDC 63187-046-15 Bottles of 20 NDC 63187-046-20 Bottles of 21 NDC 63187-046-21 Bottles of 28 NDC 63187-046-28 Bottles of 30 NDC 63187-046-30 Bottles of 40 NDC 63187-046-40 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 219 words ▾

DESCRIPTION Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16 H 17 N 3 O 4 S • H 2 O and the molecular weight is 365.41.

Cephalexin has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.

The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.

The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin.

The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide. Molecular Structure

💬 Information for Patients 176 words ▾

Information for Patients: Patients should be counseled that antibacterial drugs including cephalexin capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules 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 cephalexin capsules or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Prescribing cephalexin capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If an allergic reaction to cephalexin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g., epinephrine or other pressor amines, antihistamines, or corticosteroids).

Prolonged use of cephalexin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug. Cephalexin should be administered with caution in the presence of markedly impaired renal function.

Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended. Indicated surgical procedures should be performed in conjuction with antibiotic therapy. Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Information for Patients: Patients should be counseled that antibacterial drugs including cephalexin capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules 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 cephalexin capsules or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible. Drug Interactions: Metformin: In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean C max and AUC increased by an average of 34 % and 24 %, respectively, and metformin mean renal clearance decreased by 14 %. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems. Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin. Probenicid: As with o… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 49 words ▾

Nursing Mothers: The excretion of cephalexin in human milk increased up to 4 hours after a 500-mg dose; the drug reached a maximum level of 4 mcg/mL, then decreased gradually, and had disappeared 8 hours after administration. Caution should be exercised when cephalexin is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 62 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m 2 .

📚 References 96 words ▾

REFERENCES 1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Fourth Edition.

Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.

National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol.

17, No. 1, NCCLS, Wayne, PA, January, 1997. National Committee for Clinical Laboratory Standards.

Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No.

1, NCCLS, Wayne, PA, January, 1998.

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 63187-046-28

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 Cephalexin — the program that covers self-administered drugs. 10 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 Cephalexin. 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
$13.31M
Claims incl. refills
1.8M
Beneficiaries
1.6M
Spend / beneficiary
$8.47
Spend / claim
$7.30
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 FDA registers it as 63187-046-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0046-15, written without dashes as 63187004615. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63187-0046-15, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0046) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Proficient Rx LP. 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 7 other package presentations of this same product, including 6 capsules (63187-0046-06), 14 capsules (63187-0046-14), 20 capsules (63187-0046-20). 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?
Proficient Rx LP 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.
← 63187-0037-05 · Proficient 63187-0049-09 · Proficient →
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.