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Ki No Sin Calcium Carbonate 55 mg/500mg Tablet, 500 mg — NDC 84540-0322-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ki No Sin Calcium Carbonate 55 mg/500mg Tablet, 500 mg — NDC 84540-322-01 (Billing 84540-0322-01)

by NPG Bio Pharmaceuticals Co.,Ltd. · 500 mg in 1 BLISTER PACK

This is a package of 500 mg of Ki No Sin Calcium Carbonate 55 mg/500mg Tablet from NPG Bio Pharmaceuticals Co.,Ltd., marketed since Aug 2024 and currently FDA-listed. It is this product's only package size.

NDC 84540-0322-01
🏷️ FDA NDC (as labeled) 84540-322-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 84540-322-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84540 labeler · 322 product · 01 package
Package marketed since
Aug 29, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8454032201 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Calcium Carbonate (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 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0573-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0561-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0578-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0568-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0579-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0560-2026
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) 84540-322-01
Product NDC 84540-322
11-digit billing NDC 84540032201
UNII H0G9379FGK
Application # M022
SPL Set ID 21fa2bad-5b8b-8aac-e063-6394a90a9f49
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-29
Route ORAL
Dosage form TABLET
Substance CALCIUM CARBONATE
Why two NDCs? The FDA registers this code as 84540-322-01 — 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 → 84540-0322-01. 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

📗 Our plain-language guide HelloPharmacist
  • Most often it's an antacid. It relieves heartburn, acid indigestion, sour stomach and upset stomach tied to those symptoms. A few supplement products have other uses, like bone sup...
  • What is calcium carbonate usually used for?
  • You chew it when symptoms come on. Many labels say to chew or crush the tablets completely and not swallow them whole. The number of tablets varies by product, so read your label o...
  • Many labels say not to use the maximum dose for more than 2 weeks unless a doctor is supervising you. If your symptoms last longer than 2 weeks, check in with your doctor.
📖 Read our full Calcium Carbonate guide →
4
Nutrient depletion considerations

Calcium Carbonate may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Calcium Carbonate 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
84540-0322-01 You're viewing this Main listing 500 mg in 1 BLISTER PACK 2024-08-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ki No Sin 55 mg/500mgthis 84540-0322-01 NPG 500 mg — — FDA listed —
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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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.

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.

🧪 Avoiding an ingredient? See Calcium Carbonate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 6LK42KUV6W
    A natural protein fiber derived from silkworm cocoons. It's used as a binding agent and texture modifier to help hold the tablet or capsule together and improve how the medicine breaks down in your body.
  • UNII 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • UNII P6YC3EG204
    Cyanocobalamin is a synthetic form of vitamin B12. It's used in medicines as a nutritional ingredient and to help maintain the product's stability and potency over time.
  • UNII 7CTH8MD549
    A natural plant extract from gardenia fruit used as a colorant in medicines. It provides yellow to orange coloring and may help preserve product stability.
  • UNII 19FUJ2C58T
    Ginkgo biloba leaf is a plant extract used as a flavoring or coloring agent in some medicines. It may also serve as a natural ingredient to support the product's formulation.
  • UNII 750W5330FY
    Glucosamine hydrochloride is an amino sugar derived from shellfish or produced synthetically. In medicines, it serves as an active nutritional ingredient rather than a typical inactive excipient, used to support joint and cartilage function.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 60C608DPVT
    A plant extract from lotus leaves used as a natural ingredient in formulations. It may serve as an antioxidant, preservative, or botanical additive to support product stability and shelf life.
  • UNII 82LKS4QV2Y
    Poliglusam is a synthetic polymer made from glucose units linked together. It works as a binder and thickening agent to help hold the medicine's ingredients together and control how quickly the drug dissolves.
  • UNII JHQ6158A7R
    A natural liquid extracted from wine grapes, used as a flavoring and colorant to improve taste and appearance of the medicine.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesMicrocrystalline Cellulose, Chitosan, lactose, Gardenia Florida Fruit Extract, Gardenia Jasminoides Fruit Extract, Magnesium Oxide, Maltodextrin, Vitis Vinifera (Grape) Juice Powder, Hydroxypropyl Methylcellulose, Flavor, Cyanocobalamin, Magnesium Stearate, Cholecalciferol, Zinc Oxide, Glucosamine Hydrochloride, Ginkgo Biloba Leaf Extract, Nelumbo Nucifera (Lotus) Leaf Powder, Silk Extract

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerNPG Bio Pharmaceuticals Co.,Ltd.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code84540
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio8 products on file

More NDCs from NPG Bio Pharmaceuticals Co.,Ltd. labeler code 84540

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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses This health supplement can be used to aid in the improvement of body functions compromised by diabetes and kidney disease, and to help maintain normal calcium ion levels.

⏱️ Dosage and Administration 21 words ▾

Directions Adults and teenagers (18+ years): Take 2 tablets 2-3 times daily. Children aged 12-18 years: Take 1 tablet once daily.

⚠️ Warnings 9 words ▾

Warnings Ensure that the included desiccant is not ingested.

🧪 Active Ingredient 8 words ▾

Active Ingredients Calcium Carbonate (CaCO3) 5.5%, 55 mg

🧪 Inactive Ingredients 44 words ▾

Inactive Ingredients Microcrystalline Cellulose, Chitosan, lactose, Gardenia Florida Fruit Extract, Gardenia Jasminoides Fruit Extract, Magnesium Oxide, Maltodextrin, Vitis Vinifera (Grape) Juice Powder, Hydroxypropyl Methylcellulose, Flavor, Cyanocobalamin, Magnesium Stearate, Cholecalciferol, Zinc Oxide, Glucosamine Hydrochloride, Ginkgo Biloba Leaf Extract, Nelumbo Nucifera (Lotus) Leaf Powder, Silk Extract

🎯 Purpose 31 words ▾

Purposes Promotes overall health and wellness for those managing diabetes and kidney conditions by providing essential support. Helps to regulate and normalize the body’s critical signaling processes for improved physiological function.

📄 Do Not Use 41 words ▾

Warnings if you are sensitive to any of the ingredients in this product. Consult a healthcare professional before use if you are pregnant or breastfeeding. Do not exceed the recommended dosage. Swallow with sufficient water or a beverage to prevent aspiration.

📄 When Using This Product 22 words ▾

Warnings When using this product do not use more than directed. take with enough water or drink to avoid getting into airway.

📄 Stop Use and Ask a Doctor If 13 words ▾

Warnings Stop use and ask a doctor if symptoms persist or get worse.

📄 Keep Out of Reach of Children 20 words ▾

Warnings Keep out of reach of children Pregnant women are advised to consult with their healthcare provider prior to use.

📄 Package Label / Principal Display Panel 2 words ▾

Label label

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

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 Calcium Carbonate — the ingredient across all brands.

Top reported reactions

Fatigue6,943
Nausea6,462
Diarrhoea5,708
Chronic Kidney Disease5,699
Pain5,435
Dyspnoea5,189
Vomiting5,012

Age at onset

Neonate89
Infant35
Child177
Adolescent182
Adult5,184
Elderly5,139

Reporter sex

73,752 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization29,674
Death9,716
Life-threatening6,776
Disabling5,777
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5,794 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

Over-the-counter (OTC) 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 — 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) — 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

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 "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 NPG Bio Pharmaceuticals Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NPG Bio Pharmaceuticals Co.,Ltd. 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 84540-0240-01 · NPG 84540-0323-01 · NPG →
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.