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Sodium Bicarbonate Antacid 650 mg Tablet, 30-count — NDC 0615-8641-39 (Billing 00615-8641-39)

by NCS HealthCare of KY, LLC dba Vangard Labs · 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Sodium Bicarbonate Antacid 650 mg Tablet from NCS HealthCare of KY, LLC dba Vangard Labs, marketed since Mar 2015 and currently FDA-listed. It is this product's only package size.

NDC 00615-8641-39
🏷️ FDA NDC (as labeled) 0615-8641-39 billing pads the labeler segment with a zero
OTC 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

NDC database record

One package, one record: these facts belong to NDC 0615-8641-39 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0615 labeler · 8641 product · 39 package
Package marketed since
May 21, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0615864139 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Sodium Bicarbonate (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 4, 2025 — Lack of Assurance of Sterility. (PFIZER INC) · FDA recall D-0591-2025
Class II · Jul 30, 2025 — Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. (Exela Pharma Sciences LLC) · FDA recall D-0620-2025
Class II · Mar 7, 2025 — Lack of Assurance of Sterility (Exela Pharma Sciences LLC) · FDA recall D-0303-2025
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0234-2024
Class I · Oct 18, 2023 — Presence of Particulate Matter: Silicone (Exela Pharma Sciences LLC) · FDA recall D-0116-2024
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) 0615-8641-39
Product NDC 0615-8641
11-digit billing NDC 00615864139
RxCUI 198861
UNII 8MDF5V39QO
Application # M001
SPL Set ID fde4ea0c-152b-4b79-a6d8-2b0dbd9107aa
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-25
Route ORAL
Dosage form TABLET
Substance SODIUM BICARBONATE
Quick answers
  • RxCUI (RxNorm): 198861
Why two NDCs? The FDA registers this code as 0615-8641-39 — 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 → 00615-8641-39. 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 Salt solutions class.

Drug family (ATC) Salt solutions, Electrolyte solutions
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

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. By mouth, it relieves heartburn, sour stomach and acid indigestion. On the skin, some products ease itching from insect bites and poison ivy. The injecti...
  • Labels for products like Rapidol and De La Cruz Sodium Bicarbonate Antacid say to dissolve it completely in water and drink it. It can be repeated every couple of hours up to a dai...
  • Don't use the maximum dose for more than 2 weeks unless a doctor tells you to. If your symptoms last longer than 2 weeks, stop and see your doctor.
  • Antacids can interact with some prescription drugs. Please check with me or your doctor before using it if you take any.
📖 Read our full Sodium Bicarbonate guide →
4
Nutrient depletion considerations

Sodium Bicarbonate (OTC Drug) may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Sodium Bicarbonate (OTC Drug) 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
00615-8641-39 You're viewing this Main listing 30 TABLET in 1 BLISTER PACK 2026-05-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Bicarbonate Antacid 650 mg 00536-1047-10 Rugby 1000 tablets $0.013 — Availability likely —
Sodium Bicarbonate 650 mg 00904-7261-61 Major 100 tablets $0.013 — Availability likely —
Sodium Bicarbonate 650 mg 24689-0137-01 APNAR 1000 tablets $0.013 — Availability likely —
Sodium Bicarbonate 650 mg 64980-0528-10 Rising 1000 tablets $0.013 — Availability likely —
Sodium Bicarbonate 650 mg 69367-0258-10 Westminster 1000 tablets $0.013 — Availability likely —
Sodium Bicarbonate Antacid 650 mgthis 00615-8641-39 NCS 30 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 43353-0162-53 Aphena 60 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 54738-0020-03 Richmond 1000 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 55154-4324-00 Cardinal 10 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 55154-6754-00 Cardinal 10 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 55681-0332-10 TWIN 1000 tablets — — FDA listed —
Sodium Bicarbonate 650 mg 63629-8775-01 Bryant 1000 tablets — — FDA listed —
Sodium Bicarbonate 10 gr 648 mg 69618-0034-10 Reliable 1000 tablets — — FDA listed —
Sodium Bicarbonate 10 gr (650 mg) 70369-0001-01 CitraGen 1000 tablets — — FDA listed —
Sodium Bicarbonate 10 gr 650 mg 70795-1190-00 GRAXCELL 1000 tablets — — FDA listed —
Sodium Bicarbonate Antacid 650 mg 71610-0669-53 Aphena 60 tablets — — FDA listed —
Sodium Bicarbonate 10 GR. (650 MG) 77333-0827-10 Gendose 100 tablets — — Discontinued —
Sodium Bicarbonate 10 gr. (650 mg) 77333-0829-10 Gendose 1000 tablets — — FDA listed —
Sodium Bicarbonate 10 GR. (650 MG) 77333-0831-10 Gendose 100 tablets — — Discontinued —
Sodium Bicarbonate 10 GR (650 MG) 80513-0611-02 Advanced 200 tablets — — 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

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 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
ImprintCPC77
Size11 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerNCS HealthCare of KY, LLC dba Vangard Labs
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00615
First marketedMar 2015
Product typeHuman Otc Drug
Portfolio326 products on file

More NDCs from NCS HealthCare of KY, LLC dba Vangard Labs labeler code 00615

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms

⏱️ Dosage and Administration 63 words ▾

​Directions do not use the maximum dosage for more than 2 weeks tablets may be swallowed whole or dissolved in water prior to use adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

⚠️ Warnings 130 words ▾

Warnings Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Ask a doctor before use if you have a sodium restricted diet. Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🆘 Overdosage 17 words ▾

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 14 words ▾

Drug Facts Active ingredient ( in each tablet) Sodium bicarbonate 10 gr (650 mg)

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients croscarmellose sodium, microcrystalline cellulose, silica, stearic acid, talc.

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use if you have a sodium restricted diet.

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if symptoms last more than 2 weeks

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 21 words ▾

Other information each tablet contains : sodium 178 mg store in a dry place at 15° – 30°C (59° – 86°F).

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-231-4670

📄 Package Label / Principal Display Panel 6 words ▾

PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL

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 Sodium Bicarbonate (matched by generic name) — the program that covers self-administered drugs. 9 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 Sodium Bicarbonate. 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
$136.8K
Claims incl. refills
2.2K
Beneficiaries
722
Spend / beneficiary
$189.50
Spend / claim
$61.05
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 Sodium Bicarbonate Antacid (this brand).

Top reported reactions

Acute Kidney Injury1,696
Diarrhoea1,444
Renal Failure1,374
Nausea1,181
Anaemia1,110
Death1,061
Dyspnoea1,029

Reporter sex

23,110 reports

Serious outcomes

Hospitalization12,116
Death4,265
Life-threatening2,329
Disabling726
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,934 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 — Not published for this NDC No photo available yet for this listing.
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) — 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 NCS HealthCare of KY, LLC dba Vangard Labs. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NCS HealthCare of KY, LLC dba Vangard Labs 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.
← 00615-8637-39 · NCS 00615-8647-05 · NCS →
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.