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K Phos Original Potassium Phosphate, Monobasic 500 mg Tablet, Soluble, 500-count — NDC 0486-1111-05 (Billing 00486-1111-05)

by Beach Products, Inc. · 500 TABLET, SOLUBLE in 1 BOTTLE

This is a package of 500 tablets of K Phos Original Potassium Phosphate, Monobasic 500 mg Tablet, Soluble from Beach Products, Inc., marketed since Mar 1977 and currently FDA-listed; retail pharmacies pay about $0.5558 per tablet (NADAC).

NDC 00486-1111-05
🏷️ FDA NDC (as labeled) 0486-1111-05 billing pads the labeler segment with a zero
This package
Contains500-count Cost per ea$0.5558 NADAC Per package$277.90 / 500 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.7773/unit — full pricing hub ↓
Product page 00486-1111-01 Also comes in: 100 tablets 0486-1111-01
Rx only 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) 0486-1111-05
Product NDC 0486-1111
11-digit billing NDC 00486111105
NCPDP billing unit EA — each (per item)
RxCUI 1101775, 1101778
UNII 4J9FJ0HL51
SPL Set ID 04557ab3-6d21-49b4-b849-744c75b8a630
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1977-03-29
Route ORAL
Dosage form TABLET, SOLUBLE
Substance POTASSIUM PHOSPHATE, MONOBASIC

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

GPI-14 79600010020305
GPI class K-Phos
GCN Seq No 008252
GCN 09371
HICL code 017791
Ingredient (HICL) Potassium Phosphate,Monobasic
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1S
Therapeutic class — specific (HIC3) Urinary Ph Modifiers
AHFS code 40:04.00.00
AHFS class Acidifying Agents
FDB label name K-PHOS ORIGINAL TABLET
FDB brand name K-Phos Original
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008252
  • GCN: 09371
  • GPI-14 (Medi-Span): 79600010020305
  • HICL (First Databank): 017791
  • AHFS class code: 40:04.00.00
  • RxCUI (RxNorm): 1101775
Why two NDCs? The FDA registers this code as 0486-1111-05 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00486-1111-05. 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.

Clinical

Label name K-PHOS ORIGINAL TABLET Ingredient Potassium Phosphate,Monobasic
📗 Our plain-language guide HelloPharmacist
  • Great question. This IV form is used when your phosphate levels are too low to safely wait for a pill to work, or when you're not able to eat or take anything by mouth right now. I...
  • Why am I getting this through an IV instead of just taking a phosphorus pill?
  • It depends on how serious your kidney issues are. If you have severe kidney disease or are on dialysis, this specific product cannot be used — your kidneys would struggle to clear...
  • Is it safe to get this if I have kidney problems?
📖 Read our full Potassium Phosphates guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.556 $277.90 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.7773 $388.65 / 500 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Mar 2026 Jun 2026 Sep 2026 $0.557 $0.468
▲ Up 19% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00486-1111-01 0486-1111-01 Main listing 100 TABLET, SOLUBLE in 1 BOTTLE $0.5558 / ea $55.58 1977-03-29 — Active
00486-1111-05 You're viewing this 500 TABLET, SOLUBLE in 1 BOTTLE $0.5558 / ea $277.91 1977-03-29 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.5558 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, soluble in 1 bottle.
How does this package differ from NDC 00486-1111-01?
Both are K Phos Original Potassium Phosphate, Monobasic 500 mg Tablet, Soluble — the drug itself is identical. This page's package is the 500-count one, while NDC 00486-1111-01 is the 100 tablets package.
What NDC number is used to bill for this package of K Phos Original Potassium Phosphate, Monobasic 500 mg Tablet, Soluble?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
K Phos Original 500 mgthis 00486-1111-05 Beach 500 tablets $0.556 — Availability likely —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
1977
On the market since
Mar 1977
📍
2026
Currently FDA-listed
49 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

What it looks like

Color white
ShapeRound
ImprintBEACH;1111
Size11 mm
ScoringScored — splits in 2
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 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

5 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

LabelerBeach Products, Inc.
Labeler code00486
First marketedMar 1977
Product typeHuman Prescription Drug
Portfolio3 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

INDICATONS AND USAGE For use in patients with elevated urinary pH. K-PHOS® ORIGINAL helps keep calcium soluble and reduces odor and rash caused by ammoniacal urine. Also, by acidifying the urine, it increases the antibacterial activity of methenamine mandelate and methenamine hippurate.

⏱️ Dosage and Administration 55 words ▾

DOSAGE AND ADMINISTRATION Two tablets dissolved in 6-8 oz. of water 4 times daily with meals and at bedtime. For best results, let the tablets soak in water for 2 to 5 minutes, or more if necessary, and stir. If any tablet particles remain undissolved, they may be crushed and stirred vigorously to speed dissolution.

⛔ Contraindications 31 words ▾

CONTRAINDICATIONS This product is contraindicated in patients with infected phosphate stones; in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia and hyperkalemia.

🤒 Adverse Reactions 72 words ▾

ADVERSE REACTIONS Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with the use of potassium phosphate. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed with potassium administration: irregular heartbeat; dizziness; mental confusion; weakness or heaviness of legs; unusual tiredness; muscle cramps; numbness, tingling, pain, or weakness in hands or feet; numbness or tingling around lips; shortness of breath or troubled breathing.

🔄 Drug Interactions 78 words ▾

Drug Interactions The use of antacids containing magnesium, calcium, or aluminum in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia when used concurrently with potassium salts. Patients should have serum potassium level determinations at periodic intervals.

Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine. Serum salicylate levels should be closely monitored to avoid toxicity.

🤰 Pregnancy 52 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with K-PHOS® ORIGINAL. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.

🧬 Mechanism of Action 10 words ▾

ACTIONS K-PHOS® ORIGINAL is a highly effective sodium-free urinary acidifier.

📦 How Supplied / Storage and Handling 48 words ▾

HOW SUPPLIED White, scored tablet with the name BEACH and the number 1111 imprinted on each tablet. Bottles of 100 (NDC 0486-1111-01) and bottles of 500 (NDC 0486-1111-05) tablets. STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Dispense in tight, light-resistant containers with child-resistant closures.

📦 Storage and Handling 19 words ▾

STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Dispense in tight, light-resistant containers with child-resistant closures.

📋 Description 36 words ▾

DESCRIPTION Each tablet contains potassium acid phosphate 500 mg. Each tablet yields approximately 114 mg of phosphorus and 144 mg of potassium or 3.7 mEq. Inactive ingredients: Magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid.

💬 Information for Patients 75 words ▾

Information for Patients Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, calcium, or magnesium, which may prevent the absorption of phosphate. To assure against gastrointestinal injury associated with oral ingestion of concentrated potassium salt preparations, patients should be instructed to dissolve tablets completely in an appropriate amount of water before taking.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General This product contains potassium and should be used with caution if regulation of this element is desired. Occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. If laxation persists to an unpleasant degree, reduce the daily dosage until this effect subsides or, if necessary, discontinue the use of this product.

Caution should be exercised when prescribing this product in the following conditions: Cardiac disease (particularly in digitalized patients); severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate levels may increase the incidence of extra-skeletal calcification.

Information for Patients Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, calcium, or magnesium, which may prevent the absorption of phosphate. To assure against gastrointestinal injury associated with oral ingestion of concentrated potassium salt preparations, patients should be instructed to dissolve tablets completely in an appropriate amount of water before taking.

Laboratory Tests Careful monitoring of renal function and serum calcium, phosphorus and potassium may be required at periodic intervals during potassium phosphate therapy. Other tests may be warranted in some patients, depending on conditions. Drug Interactions The use of antacids containing magnesium, calcium, or aluminum in conjunction with phosphate preparations may bind the phosphate and prevent its absorption.

Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia when used concurrently with potassium salts. Patients should have serum potassium level determinations at periodic intervals. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine.

Serum salicylate levels should be closely monitored to avoid toxicity. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term or reproduction studies in animals or humans have been performed with K-PHOS® ORIGINAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential. Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with K-PHOS® ORIGINAL.

It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term or reproduction studies in animals or humans have been performed with K-PHOS® ORIGINAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

📄 Package Label / Principal Display Panel 66 words ▾

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label NDC 0486-1111-01 K-PHOS ® Original (Sodium-Free) POTASSIUM ACID PHOSPHATE URINARY ACIDIFIER Rx ONLY 100 TABLETS Beach PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label NDC 0486-1111-05 K-PHOS ® Original (Sodium-Free) POTASSIUM ACID PHOSPHATE URINARY ACIDIFIER Rx ONLY 500 TABLETS Beach PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
249
Gross reimbursed last 4 qtrs
$193.54
Avg / prescription
$17.59
Avg / unit
$0.7773
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$0.7773
gross reimbursed
vs
NADAC / ea
$0.5558
acquisition cost
=
Spread
+$0.2215
+40% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 11 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 249 units · 2.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.12.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 2.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets00486-1111-01 2,957 Rx · $129,843
500 tablets this page00486-1111-05 11 Rx · $194
Drug total (last 4 qtrs): 2,968 Rx · 202,217 units · $130,036 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for K-Phos Original — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 K-Phos Original. 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
$36.9K
Claims incl. refills
891
Beneficiaries
528
Spend / beneficiary
$69.88
Spend / claim
$41.41
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for K Phos Original (this brand).

Top reported reactions

Respiratory Failure48
Condition Aggravated41
Febrile Neutropenia36
Diarrhoea31
Fatigue30
Toxic Epidermal Necrolysis30
Nausea27

Age at onset

Adolescent6
Adult43
Elderly64

Reporter sex

0 reports
Male · 61%
Female · 39%

Serious outcomes

Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 72 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Beach Products, 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 1 other package presentation of this same product, including 100 tablets (00486-1111-01). 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?
Beach Products, 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.
← 00485-0254-01 · EDWARDS 00486-1125-01 · Beach →
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.