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Sodium Bicarbonate 650 mg Tablet, 1,000-count — NDC 69367-0258-10 package photo

Sodium Bicarbonate 650 mg Tablet, 1,000-count

by Westminster Pharmaceuticals, LLC · 1000 TABLET in 1 BOTTLE (69367-258-10)
NDC 69367-0258-10
🏷️ FDA NDC (as labeled) 69367-258-10 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 69367-258-10
Product NDC 69367-258
11-digit billing NDC 69367025810
NCPDP billing unit EA — each (per item)
RxCUI 198861
UNII 8MDF5V39QO
Application # M001
SPL Set ID 9dcfc778-5fd6-4c68-8d37-a5385e374617
Mechanism of action Alkalinizing Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-10-10
Route ORAL
Dosage form TABLET
Substance SODIUM BICARBONATE
GPI-14 48200010000325
GCN Seq No 002661
GCN 07855
HICL code 000523
Ingredient (HICL) Sodium Bicarbonate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name SODIUM BICARB 650 MG TABLET
FDB brand name Sodium Bicarbonate
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 69367-258-10 — 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 → 69367-0258-10. 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.

🏭 Manufacturer & labeler

LabelerWestminster Pharmaceuticals, LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code69367
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio186 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 SODIUM BICARB 650 MG TABLET Ingredient Sodium Bicarbonate
📖 What it is MedlinePlus · NLM

Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. 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
  • Sodium bicarbonate antacids work fast for occasional heartburn, but they're not meant for daily long-term use on your own. Most labels say not to use the maximum dose for more than...
  • Can I use this for my heartburn every day?
  • The active ingredient is the same — sodium bicarbonate. Products like Arm and Hammer Baking Soda are actually FDA-labeled for both antacid use and skin soaks or compresses for irri...
  • Is baking soda from the kitchen the same as these antacid products?
📖 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.

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.

💊 What it looks like

Color White
ShapeRound
ImprintS65
Size1 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 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 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.

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

The official label also statesMicrocrystalline cellulose and stearic acid

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.

💲 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 $0.013 $12.80 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.0895 $89.50 / 1000 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
Nov 2022 Dec 2025 Apr 2026 Sep 2026 $0.014 $0.013
▼ Down 4% over the last 14 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
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 mgthis 69367-0258-10 Westminster 1000 tablets $0.013 — Availability likely —
Sodium Bicarbonate Antacid 650 mg 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

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 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.

🗺️ 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 69367-0258-10, 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
18.2K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$161K
Avg / prescription
$8.83
Avg / unit
$0.0895
Latest quarter Q1 2026
4.8KRx
Medicaid pays / ea
$0.0895
gross reimbursed
vs
NADAC / ea
$0.0128
acquisition cost
=
Spread
+$0.0767
+599% 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 ⓘ
61% FFS 39% MCO
Fee-for-service · 11,165 Rx Managed care · 7,079 Rx
State Medicaid map
Alaska: no data reported AK Maine: 8,105 units · 581 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 5,740 units · 733 per 100k residents ND Minnesota: 55,124 units · 961 per 100k residents MN Wisconsin: 65,887 units · 1,115 per 100k residents WI Michigan: 102,651 units · 1,023 per 100k residents MI New York: 265,811 units · 1,358 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,806 units · 129 per 100k residents NH Oregon: 12,698 units · 300 per 100k residents OR Nevada: 11,966 units · 375 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 3,626 units · 113 per 100k residents IA Illinois: 44,965 units · 358 per 100k residents IL Indiana: 54,486 units · 794 per 100k residents IN Ohio: 92,100 units · 782 per 100k residents OH Pennsylvania: 240,495 units · 1,856 per 100k residents PA New Jersey: 54,363 units · 585 per 100k residents NJ Massachusetts: 9,595 units · 137 per 100k residents MA California: 503,472 units · 1,292 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 3,407 units · 172 per 100k residents NE Missouri: no data reported MO Kentucky: 101,109 units · 2,234 per 100k residents KY West Virginia: no data reported WV Virginia: 46,512 units · 534 per 100k residents VA Maryland: 5,738 units · 92.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 24,564 units · 331 per 100k residents AZ New Mexico: 5,705 units · 270 per 100k residents NM Kansas: no data reported KS Arkansas: 7,333 units · 239 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 42,088 units · 783 per 100k residents 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: 8,939 units · 81.0 per 100k residents GA D.C.: 2,681 units · 395 per 100k residents DC Hawaii: 17,853 units · 1,244 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
81.02,234
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 Kentucky 2,234 /100k
2 Pennsylvania 1,856 /100k
3 New York 1,358 /100k
4 California 1,292 /100k
5 Hawaii 1,244 /100k
6 Wisconsin 1,115 /100k
7 Michigan 1,023 /100k
8 Minnesota 961 /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.

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

Medicare Part D (outpatient prescription) spending for Sodium Bicarbonate — 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 — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury2,258
Renal Failure1,927
Chronic Kidney Disease1,858
Diarrhoea1,666
Nausea1,579
Vomiting1,291
Pain1,204

Age at onset

Neonate66
Infant41
Child132
Adolescent102
Adult2,519
Elderly2,003

Reporter sex

28,069 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization13,189
Death4,590
Life-threatening2,443
Disabling841
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2,153 1,007
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69367-0258-10 You're viewing this 1000 TABLET in 1 BOTTLE (69367-258-10) 2022-10-10 Active

📄 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 13 words ▾

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

⏱️ Dosage and Administration 56 words ▾

Directions Adults Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking. DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

⚠️ Warnings 182 words ▾

Warnings Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Stomach Warning TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product. Drug Interaction Precaution Ask a physician or pharmacist before use if you are presently taking a prescription drug.

Antacids may interact with certain prescription drugs. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

📦 Storage and Handling 25 words ▾

Other information each tablet contains: sodium 178 mg (7.74 mEq) store at room temperature 15º-30ºC (59º-86°F) in a well-closed container as defined in the USP

🧪 Active Ingredient 11 words ▾

Active ingredient (in each tablet) Sodium Bicarbonate 10 gr (650 mg)

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients Microcrystalline cellulose and stearic acid

🎯 Purpose 2 words ▾

Purpose Antacid

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