Pantoprazole Sodium 40 mg Tablet, Delayed Release
by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG (55154-0289-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
NDC 55154-0289-00
🏷️ FDA NDC (as labeled)
55154-0289-0
billing pads the package segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
55154-0289-0
Product NDC
55154-0289
11-digit billing NDC
55154028900
Application #
ANDA090970
SPL Set ID
95533114-68c6-4983-bc78-5bde70600c95
Established class (EPC)
Proton Pump Inhibitor
Mechanism of action
Proton Pump Inhibitors
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-14
Route
ORAL
Dosage form
TABLET, DELAYED RELEASE
Substance
PANTOPRAZOLE SODIUM
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 55154-0289-0 — a 5-4-1 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 package segment → 55154-0289-00. 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
LabelerCardinal Health 107, LLC
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA090970 (ANDA)
Labeler code55154
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio477 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
📗 Our plain-language guide HelloPharmacist
- Pantoprazole shuts down the pumps in your stomach that produce acid. Most people notice relief from heartburn and related symptoms within a few days of starting it, but the full he...
- What exactly does pantoprazole do, and how quickly will I feel better?
- It depends on the form you're taking. If you're on the delayed-release tablet, you can take it with or without food — meals just delay it a bit but don't affect how much gets absor...
- Does it matter when I take pantoprazole — with food or without?
Patient education
Supplement & herbal interactions
9
Nutrient depletion considerations
Pantoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.
CALCIUM
Insignificant Depletion
FOLIC ACID
Insignificant Depletion
IRON
Insignificant Depletion
MAGNESIUM
Major Depletion
ZINC
Insignificant Depletion
+4 more
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 pantoprazole sodium?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
yellow
ShapeOval
ImprintM;P9
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 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
-
UNII 40UAA97IT9
Crospovidone is a synthetic polymer derived from povidone. It absorbs liquid quickly and swells, helping tablets and capsules break apart and dissolve faster in your stomach.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII T967IEU43C
A synthetic polymer made from methacrylic acid and ethyl acrylate. It forms a protective coating on tablets and capsules to control how and where the medicine dissolves in the digestive system.
-
UNII K0KQV10C35
Povidone K25 is a synthetic polymer made from vinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach for better absorption.
-
UNII RDH86HJV5Z
Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
-
UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
14 inactive ingredients listed in the exact product block matched to this NDC.
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 each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pantoprazole Sodium 40 mg 00378-6689-10 | Mylan | 1000 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 62175-0617-43 | Lannett | 1000 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 13668-0429-05 | Torrent | 500 tablets | $0.035 | AB | Availability likely | — |
| pantoprazole sodium 40 mg 70010-0191-09 | Granules | 90 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 35573-0428-80 | Burel | 10 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 64980-0677-09 | Rising | 90 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 62135-0534-08 | Chartwell | 450 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 72603-0746-01 | NorthStar | 500 tablets | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 60687-0736-01 | American | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 51079-0051-20 | Mylan | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 50268-0639-15 | AvPAK | 1 tablet | $0.035 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 00904-6870-45 | Major | 1 tablet | $0.035 | AB | Availability likely | — |
| Protonix Delayed-Release 40 mg 00008-0841-81 | Wyeth | 90 tablets | $14.215 | AB | Availability likely | — |
| Pantoprazole Sodium 40 mg 63187-0938-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-5378-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 00904-6474-45 | Major | 1 tablet | — | AB | Discontinued | — |
| Pantoprazole Sodium 40 mg 42708-0185-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium DR 40 mg 80425-0133-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium DR 40 mg 80425-0162-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 67046-0536-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-1963-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 65862-0560-10 | Aurobindo | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71335-0310-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 48433-0081-20 | Safecor | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-4917-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 00615-7629-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 42708-0180-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 43353-0027-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-4165-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-4382-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 70518-0860-00 | REMEDYREPACK | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-7512-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 70518-1298-01 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 71335-1429-01 | Bryant | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 50090-5379-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 51407-0613-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72789-0086-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 76420-0806-10 | Asclemed | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 51655-0797-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 55154-7634-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 68071-4895-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 72162-1746-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 85534-0061-00 | HAWAII | 10 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 87441-0066-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Pantoprazole Sodium 40 mg 67296-1812-07 | Redpharm | 14 tablets | — | AB | Discontinued | — |
| Pantoprazole Sodium 40 mgthis 55154-0289-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Pantoprazole Sodium — the program that covers self-administered drugs. 30 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 Pantoprazole Sodium. 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
$79.44M
Claims incl. refills
6.9M
Beneficiaries
4.9M
Spend / beneficiary
$16.30
Spend / claim
$11.55
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 Pantoprazole Sodium — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
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 |
|---|---|---|---|
| 55154-0289-00 You're viewing this | 10 BLISTER PACK in 1 BAG (55154-0289-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2026-09-14 | Active |
🧭 About this NDC listing & data coverage
Finished prescription 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 | ✓ Available |
| 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
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 FDA registers it as 55154-0289-0, 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: 55154-0289-00, written without dashes as 55154028900. 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 55154-0289-00, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (0289) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.