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Pantoprazole Sodium 40 mg Tablet, Delayed Release, 30-count

by Proficient Rx LP · 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-30)

NDC 63187-0938-30

🏷️ FDA NDC (as labeled) 63187-938-30 billing pads the product segment with a zero

This package

Contains30-count Pack sizes3 compare ↓

Also priced by: Part D plans $0.1305/unit — full pricing hub ↓

Also comes in: 60 tablets 63187-0938-60 90 tablets 63187-0938-90

Rx only Generic 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 →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63187-938-30

Product NDC 63187-938

11-digit billing NDC 63187093830

NCPDP billing unit EA — each (per item)

RxCUI 314200

UNII 6871619Q5X

UPC 0363187938307

Application # ANDA078281

SPL Set ID a03aa46f-9eb5-4cf4-addf-745d94af8261

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 2011-01-20

Route ORAL

Dosage form TABLET, DELAYED RELEASE

Substance PANTOPRAZOLE SODIUM

GPI-14 49270070100620

GPI class Pantoprazole Sodium

GCN Seq No 027462

GCN 40120

HICL code 022008

Ingredient (HICL) Pantoprazole Sodium

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 D4J

Therapeutic class — specific (HIC3) Proton-Pump Inhibitors

AHFS code 56:28.36.00

AHFS class Proton-Pump Inhibitors

FDB label name PANTOPRAZOLE SOD DR 40 MG TAB

FDB brand name Pantoprazole Sodium

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 63187-938-30 — 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 → 63187-0938-30. 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 Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor

Drug family (ATC) Proton pump inhibitors

How it works Proton Pump Inhibitors

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

LabelerProficient Rx LP

Application holderLANNETT CO INC

FDA applicationANDA078281 (ANDA)

Labeler code63187

First marketedJan 2011

Product typeHuman Prescription Drug

Portfolio1,723 products on file

🔎 All NDCs from Proficient Rx LP

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 PANTOPRAZOLE SOD DR 40 MG TAB Ingredient Pantoprazole Sodium

📖 What it is MedlinePlus · NLM

Pantoprazole is used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older. Pantoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Pantoprazole is in a class of medications called proton-pump inhibitors....

Read the full MedlinePlus article ↗

📗 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?

📖 Read our full Pantoprazole guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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

🧪 Full Pantoprazole 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.

💊 What it looks like

Color White

ShapeOval

Imprint17

Size12 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 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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 R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 74G4R6TH13
A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
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.
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.

9 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 · Q2 2026	$0.1305	$3.92 / 30 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.

🔁 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 00904-6870-45	Major	1 tablet	$0.035	AB	Availability likely	—
Pantoprazole Sodium 40 mg 13668-0429-05	Torrent	500 tablets	$0.035	AB	Availability likely	—
Pantoprazole Sodium 40 mg 31722-0713-10	Camber	1000 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 50268-0639-15	AvPAK	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 60687-0736-01	American	1 tablet	$0.035	AB	Availability likely	—
Pantoprazole Sodium 40 mg 62135-0534-08	Chartwell	450 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 64980-0677-09	Rising	90 tablets	$0.035	AB	Availability likely	—
pantoprazole sodium 40 mg 70010-0191-09	Granules	90 tablets	$0.035	AB	Availability likely	—
Pantoprazole sodium delayed-release 40 mg 70756-0019-12	Lifestar	1000 tablets	$0.035	—	Availability likely	—
Pantoprazole 40 mg 72603-0178-01	NorthStar	90 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 82009-0011-90	Quallent	90 tablets	$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 00615-7629-05	NCS	15 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 00904-6474-45	Major	1 tablet	—	AB	Discontinued	—
Pantoprazole Sodium 40 mg 42708-0104-30	QPharma	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 42708-0180-30	QPharma	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 42708-0185-30	QPharma	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 43353-0027-30	Aphena	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 48433-0081-20	Safecor	1 tablet	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 50090-5378-00	A-S	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 50090-5379-00	A-S	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 50090-5794-00	A-S	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 50090-7512-00	A-S	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 51407-0613-10	Golden	1000 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 51655-0797-52	Northwind	30 tablets	—	AB	FDA listed	—
Pantoprazole 40 mg 55111-0333-01	Dr.	100 tablets	—	—	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 55154-7634-00	Cardinal	1 tablet	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 60760-0679-30	St.	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 63187-0654-30	Proficient	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mgthis 63187-0938-30	Proficient	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 63187-0974-30	Proficient	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 65162-0637-03	Amneal	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 65862-0560-10	Aurobindo	10 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 68071-2215-03	NuCare	30 tablets	—	AB	FDA listed	—
Pantoprazole 40 mg 68071-3524-03	NuCare	30 tablets	—	AB	FDA listed	—
Pantoprazole 40 mg 68071-3995-09	NuCare	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 68071-4864-09	NuCare	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 68071-4895-09	NuCare	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 68071-4917-04	NuCare	14 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 68788-8644-01	Preferred	100 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 70518-0860-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 70518-1298-01	REMEDYREPACK	1 tablet	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 71335-0310-01	Bryant	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 71335-0551-01	Bryant	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 71335-1429-01	Bryant	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 71610-0653-30	Aphena	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 72162-1746-03	Bryant	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium DR 40 mg 72189-0514-90	Direct_Rx	90 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 72789-0086-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 72789-0268-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 72865-0230-10	XLCare	1000 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 76420-0669-10	Asclemed	10 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 76420-0674-01	Asclemed	100 tablets	—	AB	FDA listed	—
Pantoprazole Sodium 40 mg 76420-0806-10	Asclemed	10 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 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	—

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

🏛️

2011

On the market since

Jan 2011

📍

2026

Currently FDA-listed

15 years listed

🔓

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

Chronic Kidney Disease24,469

Acute Kidney Injury13,851

Fatigue11,414

Renal Failure10,872

Nausea10,512

Pain9,851

Dyspnoea9,567

Age at onset

Neonate48

Infant9

Child47

Adolescent91

Adult11,041

Elderly9,348

Reporter sex

Male · 37%

Female · 63%

Unknown · 0%

Serious outcomes

Hospitalization52,368

Life-threatening7,524

Disabling6,247

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
63187-0938-30 You're viewing this	30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-30)	2017-12-01	Active
63187-0938-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-60)	2017-12-01	Active
63187-0938-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-90)	2017-12-01	Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0938-30?

NDC 63187-0938-30 is a 30-count package — 30 tablet, delayed release in 1 bottle.

What is the difference between NDC 63187-0938-30 and NDC 63187-0938-60?

Both are Pantoprazole Sodium 40 mg Tablet, Delayed Release — the drug itself is identical. NDC 63187-0938-30 is the 30-count package, while NDC 63187-0938-60 is the 60 tablets package.

What NDC number is used to bill for this package of Pantoprazole Sodium 40 mg Tablet, Delayed Release?

Bill NDC 63187-0938-30 — the 11-digit billing format is 63187093830. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 63187-938-30, 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: 63187-0938-30, written without dashes as 63187093830. 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 63187-0938-30, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0938) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Proficient Rx LP. 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 2 other package presentations of this same product, including 60 tablets (63187-0938-60), 90 tablets (63187-0938-90). 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?

Proficient Rx LP 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.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 198 words ▾

1 INDICATIONS AND USAGE Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 1.3 )

1.1Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

1.2Maintenance of Healing of Erosive Esophagitis Pantoprazole is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

1.3Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 ) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis ( 2.1 ) Adults 40 mg Once Daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 ) Adults 40 mg Twice Daily See full prescribing information for administration instructions

2.1Recommended Dosing Schedule Pantoprazole is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1. Table 1: Recommended Dosing Schedule for Pantoprazole Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered.

Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

2.2Administration Instructions Directions for method of administration for each dosage form are presented in Table 2. Table 2: Administration Instructions Formulation Route Instructions Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed. Delayed-Release Tablets Oral Swallowed whole, with or without food Pantoprazole Sodium Delayed-Release Tablets Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach.

If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets: • 40 mg, white oval biconvex tablets debossed with "17" on one side • 20 mg, white oval biconvex tablets imprinted in black ink with "KU" on one side and "180" on the other side • Delayed-Release Tablets, 20 mg and 40 mg ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [ see Adverse Reactions ( 6 ) ]. Proton pump inhibitors (PPIs), including Pantoprazole, are contraindicated in patients receiving rilpivirine-containing products [ see Drug Interactions ( 7 ) ].

Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4 ) Patients receiving rilpivirine-containing products ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Interstitial Nephritis: Observed in patients taking PPIs.

( 5.2 ) Clostridium difficile-associated diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole and refer to specialist for evaluation.

( 5.5 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.6 ) Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. ( 5.7 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with Pantoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2Acute Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including Pantoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Pantoprazole if acute interstitial nephritis develops [ see Contraindications ( 4 ) ] .

5.3Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like Pantoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [ see Adverse Reactions ( 6.2 ) ]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.4Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [ see Dosage and Administration ( 2 ) and Adverse Reactions ( 6.2 ) ].

5.5Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.

PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Pant…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis [ see Warnings and Precautions ( 5.2 ) ] Clostridium difficile- Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Bone Fracture [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Cutaneous and Systemic Lupus Erythematosus [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Cyanocobalamin (Vitamin B-12) Deficiency [ see Warnings and Precautions ( Error!

Hyperlink reference not valid. ) ] 1. Hypomagnesemia [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Most common adverse reactions are: For adult use (>2%) headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

( 6.1 ) For pediatric use (>4%) URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or Error! Hyperlink reference not valid. .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral Pantoprazole (20 mg or 40 mg), 299 patients on an H 2 -receptor antagonist, 46 patients on another PPI, and 82 patients on placebo.

The most frequently occurring adverse reactions are listed in Table 3. Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Pantoprazole (n=1473) % Comparators (n=345) % Placebo (n=82) % Headache 12.2 12.8

8.5Diarrhea 8.8 9.6

4.9Nausea 7.0 5.2

9.8Abdominal pain 6.2 4.1

6.1Vomiting 4.3 3.5

2.4Flatulence 3.9 2.9

3.7Dizziness 3.0 2.9

1.2Arthralgia 2.8 1.4

1.2Additional adverse reactions that were reported for Pantoprazole in clinical trials with a frequency of ≤ 2% are listed below by body system: Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia, thrombocytopenia Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Pediatric Patients Safety of Pantoprazole in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials.

Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to Pantoprazole are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported (> 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use in Specific Populations ( 8.4 ) . Additional adverse reactions that were reported for Pantoprazole in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system: Body as a Whole: allergic reaction, facial edema Gastrointestinal: constipation, flatulence, nausea Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase) Musculoskeletal: arthralgia, myalgia Nervous: dizziness, vertigo Skin and Appendages: urticaria The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with Pantoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically relevant Interactions Affecting Drugs Co-Administered with Pantoprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.

The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with Pantoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with Pantoprazole may increase toxicity .

There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole sodium. Intervention: Rilpivirine-containing products: Concomitant use with Pantoprazole is contraindicated [ see Contraindications ( 4 ) ]. Atazanavir: See prescribing information for atazanavir for dosing information.

Nelfinavir: Avoid concomitant use with Pantoprazole. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.

Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole sodium, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range. Methotrexate Clinical Impact: Concomitant use of pantoprazole sodium with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [ see Warnings and Precautions ( 5.10 ) ].

Intervention: A temporary withdrawal of Pantoprazole may be considered in some patients receiving high-dose methotrexate. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole) Clinical Impact: Pantoprazole sodium can reduce the absorption of other drugs due to its effect on reducing intragastric acidity Intervention: Mycophenolate mofetil (MMF): Co-administration of pantoprazole sodium in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Pantoprazole Sodium for Injection and MMF. Use Pantoprazole with caution in transplant patients receiving MMF [ see Clinical Pharmacology ( 12.3 ) ]. See the prescribing information for other drugs dependent on gastric pH for absorption.

False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs, including Pantoprazole [ see Warnings and Precautions ( 5.9 ) ]. Intervention: An alternative confirmatory method should be considered to verify positive results. See full prescribing information for a list of clinically important drug interactions( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole.

A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg).

There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium. The clinical relevance of this finding is not known.

Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of Pantoprazole for short-term treatment (up to eight weeks) of erosive esophagitis (EE) associated with GERD have been established in pediatric patients 1 year through 16 years of age. Effectiveness for EE has not been demonstrated in patients less than 1 year of age. In addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available.

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~3 min read ▾

Therefore, Pantoprazole is indicated for the short-term treatment of EE associated with GERD for patients 5 years and older. The safety and effectiveness of Pantoprazole for pediatric uses other than EE have not been established. 1 year through 16 years of age Use of Pantoprazole in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of EE associated with GERD is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of Pantoprazole for treatment of EE associated with GERD in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [ see Clinical Studies ( 14.1 ), and Clinical Pharmacology ( 12.3 ) ].

Safety of Pantoprazole in the treatment of EE associated with GERD in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel-treatment studies, involving 249 pediatric patients, including 8 with EE (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). The children ages 1 year to 5 years with endoscopically diagnosed EE (defined as an endoscopic Hetzel-Dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of Pantoprazole (approximating 0.6 mg/kg or 1.2 mg/kg).

All 4 of these patients with EE were healed (Hetzel-Dent score of 0 or 1) at 8 weeks. Because EE is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic GERD were also included in these studies. Patients were treated with a range of doses of Pantoprazole once daily for 8 weeks.

For safety findings see Adverse Reactions (6.1) . Because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of Pantoprazole for symptomatic GERD in the pediatric population. The effectiveness of Pantoprazole for treating symptomatic GERD in pediatric patients has not been established.

Although the data from the clinical trials support use of Pantoprazole for the short-term treatment of EE associated with GERD in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [ see Dosage and Administration ( 2 ) ]. In a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of

2.4L/h. Following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. The estimated AUC for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean AUC value of 6.8 mcg•hr/mL.

Neonates to less than one year of age Pantoprazole was not found to be effective in a multicenter, randomized, double-blind, placebo-controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. Patients were enrolled if they had symptomatic GERD based on medical history and had not responded to non-pharmacologic interventions for GERD for two weeks. Patients received Pantoprazole daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive Pantoprazole treatment or placebo for the subsequent four weeks in a double-blind manner.

Efficacy was assessed by observin…

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use In short-term US clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with Pantoprazole were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

🆘 Overdosage 88 words ▾

10 OVERDOSAGE Experience in patients taking very high doses of Pantoprazole (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of Pantoprazole. Pantoprazole is not removed by hemodialysis.

In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

12.2Pharmacodynamics Antisecretory Activity Under maximal acid stimulatory conditions using pentagastrin, a dose-dependent decrease in gastric acid output occurs after a single dose of oral (20-80 mg) pantoprazole in healthy subjects. Pantoprazole given once daily results in increasing inhibition of gastric acid secretion. Following the initial oral dose of 40 mg pantoprazole, a 51% mean inhibition was achieved by 2.5 hours.

With once-a-day dosing for 7 days, the mean inhibition was increased to 85%. Pantoprazole suppressed acid secretion in excess of 95% in half of the subjects. Acid secretion had returned to normal within a week after the last dose of pantoprazole; there was no evidence of rebound hypersecretion.

In a series of dose-response studies, pantoprazole, at oral doses ranging from 20 to 120 mg, caused dose-related increases in median basal gastric pH and in the percent of time gastric pH was > 3 and > 4. Treatment with 40 mg of pantoprazole produced significantly greater increases in gastric pH than the 20 mg dose. Doses higher than 40 mg (60, 80, 120 mg) did not result in further significant increases in median gastric pH.

The effects of pantoprazole on median pH from one double-blind crossover study are shown in Table 5. Table 5: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH Median pH on day 7 Time Placebo 20 mg 40 mg 80 mg 8 a.m. - 8 a.m. (24 hours) 1.3

2.9 Significantly different from placebo

3.8Significantly different from 20 mg 3.9 8 a.m. - 10 p.m. (Daytime) 1.6 3.2 4.4 4.8 10 p.m. - 8 a.m. (Nighttime) 1.2 2.1 3.0

2.6Serum Gastrin Effects Fasting serum gastrin levels were assessed in two double-blind studies of the acute healing of erosive esophagitis (EE) in which 682 patients with gastroesophageal reflux disease (GERD) received 10, 20, or 40 mg of Pantoprazole for up to 8 weeks. At 4 weeks of treatment there was an increase in mean gastrin levels of 7%, 35%, and 72% over pretreatment values in the 10, 20, and 40 mg treatment groups, respectively. A similar increase in serum gastrin levels was noted at the 8-week visit with mean increases of 3%, 26%, and 84% for the three pantoprazole dose groups.

Median serum gastrin levels remained within normal limits during maintenance therapy with Pantoprazole Sodium Delayed-Release Tablets. In long-term international studies involving over 800 patients, a 2- to 3-fold mean increase from the pretreatment fasting serum gastrin level was observed in the initial months of treatment with pantoprazole at doses of 40 mg per day during GERD maintenance studies and 40 mg or higher per day in patients with refractory GERD. Fasting serum gastrin levels generally remained at approximately 2 to 3 times baseline for up to 4 years of periodic follow-up in clinical trials.

Following short-term treatment with Pantoprazole, elevated gastrin levels return to normal by at least 3 months. Enterochromaffin-Like (ECL) Cell Effects In 39 patients treated with oral pantoprazole 40 mg to 240 mg daily (majority receiving 40 mg to 80 mg) for up to 5 years, there was a moderate increase in ECL-cell density, starting after the first year of use, which appeared to plateau after 4 years. In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to pantoprazole at doses of 0.5 to 200 mg/kg/day resulted in dose-related increases in gastric ECL cell proliferation and gastric neuroendocrine (NE)-cell tumors.

Gastric NE-cell tumors in rats may resu…

🧬 Mechanism of Action 88 words ▾

📦 How Supplied / Storage and Handling 81 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white, oval biconvex delayed-release tablets debossed with "17" on one side and are available as follows: • NDC 63187-938-30, bottles of 30 • NDC 63187-938-60, bottles of 60 • NDC 63187-938-90, bottles of 90 Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature ].

📦 Storage and Handling 30 words ▾

Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature ].

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in Pantoprazole Sodium Delayed-Release Tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S ×

1.5H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties.

Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH.

At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.55 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate.

The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 4. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adverse Reactions Hypersensitivity Reactions [ see Contraindications ( Error! Hyperlink reference not valid. ) ] Acute Interstitial Nephritis [ see Warnings and Precautions ( Error!

Hyperlink reference not valid. ) ] Clostridium difficile- Associated Diarrhea [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Bone Fracture [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Cutaneous and Systemic Lupus Erythematosus [ see Warnings and Precautions ( Error!

Hyperlink reference not valid. ) ] Cyanocobalamin (Vitamin B-12) Deficiency [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Hypomagnesemia [ see Warnings and Precautions ( Error! Hyperlink reference not valid. ) ] Drug Interactions Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [Contraindications ( 4 )] , high dose methotrexate [Warnings and Precautions ( 5.10 )] and over-the-counter medications.

Pregnancy Inform female patients of reproductive potential that Pantoprazole may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )] . Administration Caution patients that Pantoprazole Sodium Delayed-Release Tablets should not be split, crushed, or chewed. Tell patients that Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach.

Let patients know that concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets. This product’s label may have been updated. For more information, call 1-844-834-0530.

Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 CIA72949N Rev. 07/2017

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP CIA77568J Rev. 07/2017 Read this Medication Guide before you start taking Pantoprazole and each time you get a refill. There may be new information.

This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Pantoprazole? Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor. Pantoprazole can cause serious side effects, including: A type of kidney problem (acute interstitial nephritis) . Some people who take proton pump inhibitor (PPI) medicines, including Pantoprazole, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Pantoprazole.

Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea . Pantoprazole may increase your risk of getting severe diarrhea.

This diarrhea may be caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. Bone fractures .

People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take Pantoprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Pantoprazole.

Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Pantoprazole, may develop certain types of lupus erythematosus or have worsening of the lupus they already have.

Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Pantoprazole can have other serious side effects. See “ Error!

Hyperlink reference not valid.?" What is Pantoprazole? Pantoprazole is a prescription medicine called a proton pump inhibitor (PPI). Pantoprazole reduces the amount of acid in your stomach.

Pantoprazole is used in adults: for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD). If needed, your doctor may decide to prescribe another 8 weeks of Pantoprazole. to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms caused by GERD. It is not known if Pantoprazole is safe and effective if used longer than 12 months (1 year).

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping. for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Pantoprazole is used in children 5 years of age and older for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) caused by GERD. It is not known if Pantoprazole is safe if used longer than 8 weeks in children. Pantoprazole is not for use in children under 5 years of age.

Who should not take Pantoprazole? Do not take Pantoprazole if you are: allergic to pantoprazole sodium or any of the other ingredients in Pantoprazole. See the end of this Medication Guide for a complete list of ingredients in Pantoprazole. allergic to any proton pump inhibitor (PPI) medicine. are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

What should I tell my doctor before taking Pa…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

arthralgia: Joint pain.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

autoimmune: Describes a condition in which the body's defense system mistakenly attacks its own healthy cells or tissues.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bone mineral density: A measurement of the amount of mineral, such as calcium, in your bones, used to estimate how strong they are.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

CK: A protein measured in a blood test that rises when muscle is being damaged.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatine kinase: A protein measured in a blood test that rises when muscle is being damaged.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cytopenia: A lower-than-normal number of one or more types of blood cells.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastroesophageal reflux disease: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

GERD: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

refractory: Describing a disease that does not respond to, or improve with, treatment.

relapse: The return of a cancer after a period of improvement or disappearance.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

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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.

Pantoprazole Sodium 40 mg Tablet, Delayed Release, 30-count

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