Sodium Bicarbonate 650 mg Tablet, 100-count
by Major Pharmaceuticals · 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7261-61) / 10 TABLET in 1 BLISTER PACK
NDC 00904-7261-61
🏷️ FDA NDC (as labeled)
0904-7261-61
billing pads the labeler 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)
0904-7261-61
Product NDC
0904-7261
11-digit billing NDC
00904726161
NCPDP billing unit
EA — each (per item)
RxCUI
198861
UNII
8MDF5V39QO
Application #
M001
SPL Set ID
ebf340c9-0b6d-13d2-e053-2995a90ae338
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
2022-10-26
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 0904-7261-61 — 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 → 00904-7261-61. 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
LabelerMajor Pharmaceuticals
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio629 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Bicarbonate (OTC Drug) — tap one for details:
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.
FOLIC ACID
Insignificant Depletion
IRON
Insignificant Depletion
PHOSPHATE SALTS
Moderate Depletion
CHROMIUM
Insufficient Evidence
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.
💬 Questions about Sodium Bicarbonate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
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 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 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.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescroscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.013 | $1.30 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.0965 | $9.65 / 100 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
▼ Down 8% over the last 12 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Bicarbonate Antacid 650 mg 00536-1047-10 | Rugby | 1000 tablets | $0.013 | — | Availability likely | — |
| Sodium Bicarbonate 650 mgthis 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 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 00904-7261-61, 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 – Q4 2025 · 4 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
758
Units reimbursed last 4 qtrs
69.6K
Gross reimbursed last 4 qtrs
$6.7K
Avg / prescription
$8.86
Avg / unit
$0.0965
Latest quarter Q4 2025
202Rx
Medicaid pays / ea
$0.0965
gross reimbursed
vs
NADAC / ea
$0.0130
acquisition cost
=
Spread
+$0.0835
+642% 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 ⓘ
Fee-for-service · 514 Rx Managed care · 244 Rx
State Medicaid map
Units reimbursed · per 100k residents
5.2158
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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
Age at onset
Reporter sex
Male · 50%
Female · 50%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00904-7261-61 You're viewing this | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-7261-61) / 10 TABLET in 1 BLISTER PACK | 2022-10-26 | 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
⏱️ Dosage and Administration
⚠️ Warnings
🆘 Overdosage
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms
⏱️ Dosage and Administration ▾
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 ▾
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 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 ▾
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
🧪 Active Ingredient ▾
Drug Facts Active ingredient (in each tablet) Sodium bicarbonate 10 gr (650 mg)
🧪 Inactive Ingredients ▾
croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc
🎯 Purpose ▾
Purpose Antacid
No label section mentions that — try another word, or open the full label on DailyMed below.
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.