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🧴no package photo
in the FDA label

Calcium Carbonate 1250 mg/5mL Suspension, 500 mL

by Hikma Pharmaceuticals USA Inc. · 500 mL in 1 BOTTLE (0054-3117-63)
NDC 00054-3117-63
🏷️ FDA NDC (as labeled) 0054-3117-63 billing pads the labeler segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0054-3117-63
Product NDC 0054-3117
11-digit billing NDC 00054311763
NCPDP billing unit ML — per mL (volume)
Application # part331
Physiologic effect Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2024)
Route ORAL
Dosage form SUSPENSION
Substance CALCIUM CARBONATE
GCN Seq No 002684
GCN 07872
HICL code 000581
Ingredient (HICL) Calcium Carbonate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1F
Therapeutic class — specific (HIC3) Calcium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name CALCIUM CARB 1,250 MG/5 ML SUS
FDB brand name Calcium Carbonate
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 0054-3117-63 — 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 → 00054-3117-63. 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.

🏭 Manufacturer & labeler

LabelerHikma Pharmaceuticals USA Inc.
FDA applicationpart331 (OTC MONOGRAPH FINAL)
Labeler code00054
Product typeHuman Otc Drug
Portfolio726 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.

🩺 Clinical

Label name CALCIUM CARB 1,250 MG/5 ML SUS Ingredient Calcium Carbonate
📖 What it is MedlinePlus · NLM

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most people use it as a fast-acting antacid to get quick relief from heartburn, acid indigestion, sour stomach, or an upset stomach. You'll find it in brands like Tums, Rolaids, an...
  • What is calcium carbonate actually used for?
  • Don't use the maximum daily dose for more than 2 weeks in a row without talking to a doctor first. If your heartburn or stomach symptoms keep coming back or don't improve, that's y...
  • How long can I keep taking this before I should see a 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.018 $8.85 / 500 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 May 2022 Jul 2022 $0.018 $0.016
▼ Down 2% over the last 7 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calcium Carbonate 1250 mg/5mLthis 00054-3117-63 Hikma 500 ml $0.018 — Discontinued —
Calcium Carbonate 1250 mg/5mL 00121-0766-16 PAI 12 bottles $0.020 — Availability likely +15%
Calcium Carbonate 1250 mg/5mL 00121-4766-05 PAI 10 cups — — FDA listed —
Calcium Carbonate 1250 mg/5mL 17856-3117-03 Atlantic 5 ml — — 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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00054-3117-63 You're viewing this 500 mL in 1 BOTTLE (0054-3117-63) 2004-11-18 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) — 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 Final". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0054-3117-63, 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: 00054-3117-63, written without dashes as 00054311763. 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 00054-3117-63, the first segment (00054) is the labeler code FDA assigned to Hikma Pharmaceuticals USA Inc.; the middle segment (3117) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (63) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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 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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 00054-3090-36 · Hikma 00054-3120-41 · Hikma →
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.