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Sodium Bicarbonate 650 mg Tablet, 60-count — NDC 43353-0162-53 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Bicarbonate 650 mg Tablet, 60-count — NDC 43353-162-53 (Billing 43353-0162-53)

by Aphena Pharma Solutions - Tennessee, LLC · 60 TABLET in 1 BOTTLE, PLASTIC

This is a package of 60 tablets of Sodium Bicarbonate 650 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since May 2015 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 43353-0162-53
🏷️ FDA NDC (as labeled) 43353-162-53 billing pads the product segment with a zero
This package
Contains60-count Pack sizes6 compare ↓
Main listing for product 43353-162 · Also comes in: 90 tablets 43353-162-60 120 tablets 43353-162-70 180 tablets 43353-162-80 200 tablets 43353-162-85 360 tablets 43353-162-94
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 43353-162-53 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43353 labeler · 162 product · 53 package
Package marketed since
Mar 30, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 4335316253 8
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) 43353-162-53
Product NDC 43353-162
11-digit billing NDC 43353016253
NCPDP billing unit EA — each (per item)
RxCUI 198861
UNII 8MDF5V39QO
Application # part331
SPL Set ID 15605a6d-6c90-47d5-9d1f-f66a3f27d5fc
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 FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-01
Route ORAL
Dosage form TABLET
Substance SODIUM BICARBONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 48200010000325
GPI class Sodium Bicarbonate
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
Quick answers
  • GSN (GCN sequence number): 002661
  • GCN: 07855
  • GPI-14 (Medi-Span): 48200010000325
  • HICL (First Databank): 000523
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 198861
Why two NDCs? The FDA registers this code as 43353-162-53 — 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 → 43353-0162-53. 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

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
  • 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.
Try another pack size: 90 tablets 120 tablets 180 tablets 200 tablets 360 tablets
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
43353-0162-53 You're viewing this Main listing 60 TABLET in 1 BOTTLE, PLASTIC 2016-03-30 — Active
43353-0162-60 43353-162-60 90 TABLET in 1 BOTTLE, PLASTIC 2016-02-22 — Active
43353-0162-70 43353-162-70 120 TABLET in 1 BOTTLE, PLASTIC 2016-02-22 — Active
43353-0162-80 43353-162-80 180 TABLET in 1 BOTTLE, PLASTIC 2016-03-30 — Active
43353-0162-85 43353-162-85 200 TABLET in 1 BOTTLE, PLASTIC 2016-03-02 — Active
43353-0162-94 43353-162-94 360 TABLET in 1 BOTTLE, PLASTIC 2016-02-22 — Active

You're viewing the smallest of 6 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle, plastic.
How does this package differ from NDC 43353-0162-60?
Both are Sodium Bicarbonate 650 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 43353-0162-60 is the 90 tablets package.
What NDC number is used to bill for this package of Sodium Bicarbonate 650 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 mg 00615-8641-39 NCS 30 tablets — — FDA listed —
Sodium Bicarbonate 650 mgthis 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
May 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
ImprintAP;119
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.

💡 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 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.

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

The official label also statescroscarmellose sodium, microcrystalline cellulose, 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.

Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
FDA applicationpart331 (OTC MONOGRAPH FINAL)
Labeler code43353
First marketedMay 2015
Product typeHuman Otc Drug
Portfolio800 products on file

More NDCs from Aphena Pharma Solutions - Tennessee, LLC labeler code 43353

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

Indications: Relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms

⏱️ Dosage and Administration 53 words ▾

Directions: Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours Dissolve tabelt completely in water before drinking. DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

⚠️ Warnings 56 words ▾

Warnings Ask a doctor or pharmacist if you are on a sodium-restricted diet. if you are taking a prescription drug. Antacids may interact with certain prescription drugs. if symptons last more than 2 weeks As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

🆘 Overdosage 15 words ▾

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

📦 Storage and Handling 24 words ▾

Other Information: each tablet contains: sodium 178 mg store at room temperature 15 ° - 30 ° C (59 ° - 86 ° F).

🧪 Active Ingredient 13 words ▾

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

🧪 Inactive Ingredients 8 words ▾

INACTIVE INGREDIENT croscarmellose sodium, microcrystalline cellulose, stearic acid

🎯 Purpose 2 words ▾

PURPOSE Antacid

📄 Ask a Doctor Before Use If 33 words ▾

Ask a doctor or pharmacist if you are on a sodium-restricted diet. if you are taking a prescription drug. Antacids may interact with certain prescription drugs. if symptons last more than 2 weeks

🤰 If Pregnant or Breast-Feeding 22 words ▾

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

📄 Keep Out of Reach of Children 11 words ▾

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

📄 Questions or Comments 27 words ▾

Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

📄 Package Label / Principal Display Panel 20 words ▾

PRINCIPAL DISPLAY PANEL - 650 mg NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only Bottle Label 650 mg

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 — 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.

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 Final". 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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 90 tablets (43353-0162-60), 120 tablets (43353-0162-70), 180 tablets (43353-0162-80). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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.
← 43353-0152-30 · Aphena 43353-0186-60 · Aphena →
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.