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PANTOPRAZOLE SODIUM 80 mg/100mL Injection, Solution — NDC 00338-9648-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PANTOPRAZOLE SODIUM 80 mg/100mL Injection, Solution — NDC 0338-9648-12 (Billing 00338-9648-12)

by Baxter Healthcare Company · 12 BAG in 1 CARTON / 100 mL in 1 BAG

This is a package of PANTOPRAZOLE SODIUM 80 mg/100mL Injection, Solution from Baxter Healthcare Company, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 00338-9648-12
🏷️ FDA NDC (as labeled) 0338-9648-12 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0338-9648-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 9648 product · 12 package
Package marketed since
Feb 14, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338964812 3
FDA record last changed
Aug 27, 2026
🚨
Active recall for this product.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0812-2026
Lots / codes: Lot # NC194129, Exp Date: 05/07/2028. · reported Sep 9, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-9648-12
Product NDC 0338-9648
11-digit billing NDC 00338964812
NCPDP billing unit ML — per mL (volume)
RxCUI 2675781, 2675784, 2675786
UNII 6871619Q5X
Application # NDA217512
SPL Set ID a476e063-9450-4793-9a22-16b0a0a61cd0
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-14
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance PANTOPRAZOLE SODIUM

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

GCN Seq No 085739
GCN 55287
HICL code 049401
Ingredient (HICL) Pantoprazole In 0.9% Sod Chlor
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 80MG/100ML-NS
FDB brand name Pantoprazole Sodium-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085739
  • GCN: 55287
  • HICL (First Databank): 049401
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 2675781
Why two NDCs? The FDA registers this code as 0338-9648-12 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-9648-12. 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.

Clinical

Label name PANTOPRAZOLE SOD 80MG/100ML-NS Ingredient Pantoprazole In 0.9% Sod Chlor
📖 What it is MedlinePlus · NLM

Pantoprazole injection is used to treat gastroesophageal reflux disease (GERD; a condition where stomach acid flows back into the esophagus (tube between the stomach and throat)) treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome Pantoprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in adults for GERD with a history of erosive esophagitis, for up to 10 days. It is also used for conditions where the stomach makes too much acid, such as Zollinger-Elli...
  • A healthcare professional gives it into your vein, either as a short injection or an infusion over about 15 minutes. For GERD it is a short course. Your team switches you to an ora...
  • Headache, diarrhea, nausea, belly pain, vomiting, gas, dizziness, and joint pain are the most common. You may also have vein irritation at the IV site. Tell your nurse if the site...
  • Get help right away for swelling, trouble breathing, hives, or a severe skin rash or blistering. Also report diarrhea that does not improve, new rash or joint pain, muscle spasms,...
📖 Read our full Pantoprazole Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer 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.
Medicare Part B allowsASP · J2472 No ASP payment limit on file for J2472 this quarter.
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.

Billing & reimbursement

FDA NDC (as labeled)0338-9648-12
11-digit billing NDC00338-9648-12
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2472
DescriptorINJECTION, PANTOPRAZOLE SODIUM IN SODIUM CHLORIDE (BAXTER), 40 MG
Billing units / pkg0.02 units
How the units are derivedThis package is 100 ML; the HCPCS unit is 40 MG, so one package = 0.02 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-9648-12 You're viewing this Main listing 12 BAG in 1 CARTON / 100 mL in 1 BAG 2024-02-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pantoprazole Sodium 80 mg/100mLthis 00338-9648-12 Baxter 100 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

  • 2 mg / 100 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 155 mg / 100 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 900 mg / 100 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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.

Manufacturer & labeler

LabelerBaxter Healthcare Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA217512 (NDA)
Labeler code00338
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio121 products on file

More NDCs from Baxter Healthcare Company labeler code 00338

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 154 words ▾

1 INDICATIONS AND USAGE Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ( 1.2 )

1.1Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.

1.2Pathological Hypersecretion Including Zollinger-Ellison Syndrome Pantoprazole sodium in 0.9% sodium chloride injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION GERD Associated with EE ( 2.1 ) • The recommended adult dosage is 40 mg given once daily by intravenous infusion for 7 to 10 days. ( 2.1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome ( 2.2 ): • The recommended adult dosage is 80 mg administered every 12 hours by intravenous infusion. For information on how to adjust dosing for individual patient needs, see the full prescribing information.

Administration ( 2.3 ): • Only for intravenous infusion. • The intravenous infusion should be administered over 15 minutes.

2.1Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis The recommended adult dosage of pantoprazole sodium in 0.9% sodium chloride injection is 40 mg given once daily by intravenous infusion for 7 to 10 days. Discontinue treatment with pantoprazole sodium in 0.9% sodium chloride injection as soon as the patient is able to receive treatment with pantoprazole delayed-release tablets or oral suspension. Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1) ] such as life-threatening upper gastrointestinal bleeds, are not available.

Pantoprazole sodium in 0.9% sodium chloride injection 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

2.2Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome The recommended adult dosage of pantoprazole sodium in 0.9% sodium chloride injection is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h.

Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14) ] . Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

2.3Preparation and Administration Instructions Only for intravenous infusion over 15 minutes; other parenteral routes of administration and infusion rates are not recommended. Fifteen Minute Infusion 1. Thaw frozen container at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F).

Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. 2.

No further dilution is necessary. 3. Check for minute leaks by squeezing container firmly.

If leaks are detected, discard solution as sterility may be impaired. 4. Do not add supplementary medication.

5. Inspect thawed pantoprazole sodium in 0.9% sodium chloride solution visually for particulate matter prior to and during administration. Thawed solution is expected to range from colorless to yellow over time..

6. Administer intravenously over a period of approximately 15 minutes. Storage Thawed solution is stable for 21 days under refrigeration 2-8°C (36 - 46°F) or 48 hours at room temperature 20-25°C (68 - 77°F).

Protect from light when stored under refrigeration. Do not refreeze the thawed solution.

2.4Compatibility Information • Administer pantoprazole sodium in 0.9% sodium chloride injection intravenously through a dedicated line or through a Y-site. • Flush the intravenous line before and after administration of pantoprazole sodium in 0.9% sodium chloride injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP. • When administered through a Y-site, pantoprazole sodium in 0.9% sodium chloride injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% S… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 135 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: Pantoprazole sodium in 0.9% sodium chloride injection is available in a ready to use single-dose GALAXY container supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic solution as follows: • 40 mg/100 mL (0.4 mg/mL), each 100 mL contains 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP) • 40 mg/50 mL (0.8 mg/mL) , each 50 mL contains 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP) • 80 mg/100 mL (0.8 mg/mL) , each 100 mL contains 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP) Injection: Pantoprazole sodium in 0.9% sodium chloride injection as available in 40 mg in 100 mL, 40 mg in 50 mL, and 80 mg in 100 mL single-dose Galaxy container.

( 3 )

⛔ Contraindications 107 words ▾

4 CONTRAINDICATIONS • Pantoprazole sodium in 0.9% sodium chloride injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2 , 5.4 ), Adverse Reactions (6) ] . • Proton pump inhibitors (PPIs), including pantoprazole sodium in 0.9% sodium chloride injection, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . • Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

(4) • Patients receiving rilpivirine-containing products. ( 4 , 7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium in 0.9% sodium chloride injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) • Injection Site Reactions : Thrombophlebitis is associated with the administration of intravenous pantoprazole.

( 5.2 ) • Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. ( 5.3 ) • Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.

( 5.4 ) • Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.5 ) • 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. ( 5.6 ) • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

( 5.7 ) • Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue pantoprazole sodium in 0.9% sodium chloride injection and refer to specialist for evaluation. ( 5.8 ) • Hepatic Effects : Elevations of transaminases observed. ( 5.9 ) • Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs.

( 5.10 ) • Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.11 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium in 0.9% sodium chloride injection 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.

5.2Injection Site Reactions Thrombophlebitis was associated with the administration of pantoprazole sodium injection.

5.3Potential for Exacerbation of Zinc Deficiency Pantoprazole sodium in 0.9% sodium chloride injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with pantoprazole sodium in 0.9% sodium chloride injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously [see Dosage and Administration (2.4) ] .

5.4Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue pantoprazole sodium in 0.9% sodium chloride injection and evaluate patients with suspected acute TIN [see Contraindications (4) ] .

5.5Clostridium difficile- Associated Diarrhea Published observational studies suggest that PPI therapy like pantoprazole sodium in 0.9% sodium chloride injection 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.

5.6Bone Fracture Several published observational studies suggest that PPI therapy may be associate… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] • Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] • Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.5) ] • Bone Fracture [see Warnings and Precautions (5.6) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] • Hepatic Effects [see Warnings and Precautions (5.9) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] • Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Most common adverse reactions (>2%) are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. Worldwide, approximately 80,500 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment. Gastroesophageal Reflux Disease (GERD) Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral pantoprazole sodium (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another PPI, and 82 patients on placebo.

The most frequently occurring adverse reactions are listed in Table 1 . The number of patients treated in comparative studies with pantoprazole sodium injection is limited; however, the adverse reactions seen were similar to those seen in the oral studies. Thrombophlebitis was the only new adverse reaction identified with pantoprazole sodium injection.

Table 1. Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2% Oral Pantoprazole Sodium (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 oral pantoprazole sodium in US clinical trials with a frequency of ≤2% are listed below by body system: Body as a Whole: allergic reaction, fever, photosensitivity reaction, facial edema, thrombophlebitis (I.V. only) Gastrointestinal: constipation, dry mouth, hepatitis Hematologic: leukopenia (reported in ex-US clinical trials only), thrombocytopenia Metabolic/Nutritional: elevated CPK (creatine phosphokinase), generalized edema, elevated triglycerides, liver function tests abnormal Musculoskeletal: myalgia Nervous: depression, vertigo Skin and Appendages: urticaria, rash, pruritus Special Senses: blurred vision Zollinger-Ellison (ZE) Syndrome In clinical studies of ZE Syndrome, adverse reactions reported in 35 patients administered pantoprazole sodium injection doses of 80 mg to 240 mg per day for up to 2 years were similar to those reported in adult patients with GERD.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of oral pantoprazole sodium and pantoprazole sodium injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are listed below by body system: General Disorders and Administration Conditions : asthenia, fatigue, m… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium injection and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2.

Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium in 0.9% Sodium Chloride Injection 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 of the antiretroviral drugs. • There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole.

Intervention: Rilpivirine-containing products : Concomitant use with pantoprazole sodium in 0.9% sodium chloride injection is contraindicated [see Contraindications (4) ] . See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information.

Nelfinavir : Avoid concomitant use with pantoprazole sodium in 0.9% sodium chloride injection See prescribing information for nelfinavir. Saquinavir : See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals : See prescribing information.

Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time.

Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Clopidogrel Clinical Impact: Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3) ].

Intervention: No dose adjustment of clopidogrel is necessary when administered with an approved dose of pantoprazole sodium in 0.9% sodium chloride injection. Methotrexate Clinical Impact: Concomitant use of PPIs 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 (5.14) ] .

Intervention: A temporary withdrawal of pantoprazole sodium in 0.9% sodium chloride injection 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/itraconazole) Clinical Impact: Pantoprazole 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 [see Clinical Pharmacology (12.3) ] .

The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving pantoprazole sodium injection and MMF. Use pantoprazole sodium in 0.9% sodium chloride injection with caution in transplant patient… [Excerpted — this section continues on DailyMed.]

👥 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 Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data) .

A pre-and post-natal 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) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4) ] .

There were no drug-related findings in maternal animals . Advise pregnant women of the potential risk of fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use.

Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (PPIs). There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=0.55, [95% Confidence Interval (CI) 0.08-3.95].

In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR=1.12 ([95% CI 0.86-1.45] and for spontaneous abortions OR=1.29 [95% CI 0.84-1.97]).

Animal Data Reproduction studies have been performed in rats at intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. A pre- and post-natal 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,… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data) .

A pre-and post-natal 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) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4) ] .

There were no drug-related findings in maternal animals . Advise pregnant women of the potential risk of fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use.

Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (PPIs). There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=0.55, [95% Confidence Interval (CI) 0.08-3.95].

In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations OR=1.12 ([95% CI 0.86-1.45] and for spontaneous abortions OR=1.29 [95% CI 0.84-1.97]).

Animal Data Reproduction studies have been performed in rats at intravenous pantoprazole doses up to 20 mg/kg/day (4 times the recommended human dose based on body surface area) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals and have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. A pre- and post-natal 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 pre… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 196 words ▾

8.4Pediatric Use The safety and effectiveness of pantoprazole sodium in 0.9% sodium chloride injection have not been established in pediatric patients. Animal Toxicity Data In a pre- and post-natal development toxicity study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day on postnatal day (PND 4) through PND 21, in addition to lactational exposure through milk. 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 and higher doses.

Changes in bone parameters were partially reversible following a recovery period [see Use in Specific Populations (8.1) ] . In neonatal/juvenile animals (rats and dogs) toxicities were similar to those observed in adult animals, including gastric alterations, decreases in red cell mass, increases in lipids, enzyme induction and hepatocellular hypertrophy. An increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies.

Full to partial recovery of these effects were noted in animals of both age groups following a recovery period.

🧓 Geriatric Use 78 words ▾

8.5Geriatric Use Of 286 patients in clinical studies of intravenous pantoprazole sodium in patients with GERD and a history of EE, 86 (43%) were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience with oral pantoprazole sodium has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 102 words ▾

10 OVERDOSAGE Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole. Pantoprazole is not removed by hemodialysis.

In case of overdose, treatment should be symptomatic and supportive. Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) 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 The magnitude and time course for inhibition of pentagastrin-stimulated acid output (PSAO) by single doses (20 to 120 mg) of pantoprazole sodium injection were assessed in a single-dose, open-label, placebo-controlled, dose-response study. The results of this study are shown in Table 3. Healthy subjects received a continuous infusion for 25 hours of pentagastrin (PG) at 1 mcg/kg/h, a dose known to produce submaximal gastric acid secretion.

The placebo group showed a sustained, continuous acid output for 25 hours, validating the reliability of the testing model. Pantoprazole sodium injection had an onset of antisecretory activity within 15 to 30 minutes of administration. Doses of 20 to 80 mg of pantoprazole sodium injection substantially reduced the 24-hour cumulative PSAO in a dose-dependent manner, despite a short plasma elimination half-life.

Complete suppression of PSAO was achieved with 80 mg within approximately 2 hours and no further significant suppression was seen with 120 mg. The duration of action of pantoprazole sodium injection was 24 hours. Table 3.

Gastric Acid Output (mEq/hr, Mean ± SD) and Percent Inhibition Compared to individual subject baseline prior to treatment with pantoprazole sodium injection. NA = not applicable. (Mean ± SD) of Pentagastrin-Stimulated Acid Output Over 24 Hours Following a Single Dose of Pantoprazole Sodium Injection Inhibition of gastric acid output and the percent inhibition of stimulated acid output in response to pantoprazole sodium injection may be higher after repeated doses. in Healthy Subjects Treatment Dose 2 hours 4 hours 12 hours 24 hours Acid Output % Inhibition Acid Output % Inhibition Acid Output % Inhibition Acid Output % Inhibition 0 mg (Placebo, n=4) 39 ± 21 NA 26 ± 14 NA 32 ± 20 NA 38 ± 24 NA 20 mg (n=4-6) 13 ± 18 47 ± 27 6 ± 8 83 ± 21 20 ± 20 54 ± 44 30 ± 23 45 ± 43 40 mg (n=8) 5 ± 5 82 ± 11 4 ± 4 90 ± 11 11 ± 10 81 ± 13 16 ± 12 52 ± 36 80 mg (n=8) 0.1 ± 0.2 96 ± 6 0.3 ± 0.4 99 ± 1 2 ± 2 90 ± 7 7 ± 4 63 ± 18 In one study of gastric pH in healthy subjects, pantoprazole sodium was administered orally (40 mg enteric coated tablets) or pantoprazole sodium injection (40 mg) once daily for 5 days and pH was measured for 24 hours following the fifth dose.

The outcome measure was median percent of time that pH was ≥4 and the results were similar for intravenous and oral medications; however, the clinical significance of this parameter is unknown. Serum Gastrin Effects Serum gastrin concentrations were assessed in two placebo-controlled studies. In a 5-day study of oral pantoprazole with 40 and 60 mg doses in healthy subjects, following the last dose on day 5, median 24-hour serum gastrin concentrations were elevated by 3- to 4-fold compared to placebo in both 40 and 60 mg dose groups.

However, by 24 hours following the last dose, median serum gastrin concentrations for both groups returned to normal levels. In another placebo-controlled, 7-day study of 40 mg intravenous or oral pantoprazole in patients with GERD and a history of EE, the mean serum gastrin concentration increased approximately 50% from baseline and as compared with placebo, but remained within the normal range. During 6 days of repeated administration of pantoprazole sodium injection in patients with ZE Syndrome, consistent changes of serum gastrin concentrations from baseline were not observed.

Enterochromaffin-Like (ECL) Cell Effects There are no data… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 88 words ▾

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).

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Pantoprazole sodium in 0.9% sodium chloride injection is supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic single-dose solution packaged in GALAXY container. The single-dose GALAXY plastic containers are available as follows: Code NDC Container Size Number of Containers/Carton 2G3571 NDC 0338-9644-12 GALAXY single-dose 100 mL 12 count of 40 mg/100 mL (0.4 mg/mL) GALAXY containers 2G3569 NDC 0338-9646-24 GALAXY single-dose 50 mL 24 count of 40 mg/50 mL (0.8 mg/mL) GALAXY containers 2G3581 NDC 0338-9648-12 GALAXY single-dose 100 mL 12 count of 80 mg/100 mL (0.8 mg/mL) GALAXY containers Storage and Handling Store frozen at or below -20°C /-4°F.

Protect from light when stored frozen. Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Storage conditions for the thawed solution are described in another section of the prescribing information. [ see Dosage and Administration (2.3) ] .

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in pantoprazole sodium in 0.9% sodium chloride injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium is a white to off-white crystalline powder and is racemic.

Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium 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. The thawed solution of pantoprazole sodium in 0.9% sodium chloride injection is in the pH range 9.0 to 10.5. Pantoprazole sodium in 0.9% sodium chloride injection is supplied for intravenous administration as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL or 100 mL single-dose GALAXY container in following presentations: 40 mg/100 mL (0.4 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; 40 mg/50 mL (0.8 mg/mL): containing 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; 80 mg/100 mL (0.8 mg/mL): containing 80 mg of pantoprazole (equivalent to 90.2 mg of pantoprazole sodium USP); 2 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; Sodium hydroxide and/or hydrochloric acid may be used to adjust pH.

The solution is intended for intravenous use after thawing to room temperature. Thawed solution is expected to range from colorless to yellow over time. Pantoprazole Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: • Injection Site Reactions [see Warnings and Precautions (5.2) ] • Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] • Acute Tubulointerstitial Nephritis [see Contraindications (4) , Warnings and Precautions (5.4) ] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.5) ] • Bone Fracture [see Warnings and Precautions (5.6) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7) ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] • Hepatic Effects [see Warnings and Precautions (5.9) ] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10) ] Drug Interactions Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [ Contraindications (4) ] and high dose methotrexate [ Warnings and Precautions (5.14) ] .

Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1) ] . This product’s labeling may have been updated.

For the most recent prescribing information, please visit www.baxter.com . Baxter logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Product of USA Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pantoprazole peak serum concentration (C max ) and area under the serum concentration-time curve (AUC) increase in a manner proportional to intravenous doses from 10 mg to 80 mg. Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following the administration of pantoprazole sodium injection, the serum concentration of pantoprazole declines biexponentially with a terminal elimination half-life of approximately one hour.

In CYP2C19 extensive metabolizers [see Clinical Pharmacology (12.5) ] with normal liver function receiving a 40 mg dose of pantoprazole sodium injection. by constant rate over 15 minutes, the peak concentration (C max ) is 5.52 ±1.42 mcg/mL and the total area under the plasma concentration versus time curve (AUC) is 5.4 ±1.5 mcg hr/mL. The total clearance is 7.6 to 14 L/h. Distribution The apparent volume of distribution of pantoprazole is approximately 11 to

23.6L, distributing mainly in extracellular fluid. The serum protein binding of pantoprazole is about 98%, primarily to albumin. Elimination Metabolism Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system.

Pantoprazole metabolism is independent of the route of administration (intravenous or oral). The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.

CYP2C19 displays a known genetic polymorphism due to its deficiency in some sub-populations (e.g., 3% of Caucasians and African-Americans and 17 to 23% of Asians). Although these sub-populations of slow pantoprazole metabolizers have elimination half-life values from 3.5 to 10 hours, they still have minimal accumulation (23% or less) with once daily dosing. Excretion After administration of a single intravenous dose of 14 C-labeled pantoprazole sodium to healthy, extensive CYP2C19 metabolizers, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion.

There was no renal excretion of unchanged pantoprazole. Specific Populations Geriatric Patients After repeated intravenous administration in elderly subjects (65 to 76 years of age), the AUC and elimination half-life values of pantoprazole were similar to those observed in younger subjects. Male and Female Patients After oral administration there was a modest increase in the AUC and C max of pantoprazole in women compared to men.

However, weight-normalized clearance values are similar in women and men. Patients with Renal Impairment In patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. Patients with Hepatic Impairment In patients with mild to severe hepatic impairment (Child-Pugh Class A to C), maximum pantoprazole concentrations increased only slightly (1.5-fold) relative to healthy subjects when pantoprazole sodium was administered orally.

Although serum half-life values increased to 7 to 9 hours and AUC values increased by 5 to 7-fold in hepatic-impaired patients, these increases were no greater than those observed in CYP2C19 poor metabolizers, where no dosage adjustment is warranted. These pharmacokinetic changes in hepatic-impaired patients result in minimal drug accumulation following once-daily, multiple-dose administration. Oral pantoprazole doses higher than 40 mg per day have not been studied in hepatically impaired patients.

Drug Interaction Studies Effect of Other Drugs on Pantoprazole Pantoprazole is metabolized mainly by CYP2C19 and to minor extents by CYPs 3A4, 2D6 and 2C9. In in vivo drug-drug interaction studies with CYP2C19 substrates (diazepam [also a CYP3A4 substrate] and phenytoin [also a CYP3A4 inducer]), nifedipine, midazolam, and clarithromycin (CYP3A4 substrates), metoprolol (a CYP2D6 substrate), diclofenac, naproxen… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Antisecretory Activity The magnitude and time course for inhibition of pentagastrin-stimulated acid output (PSAO) by single doses (20 to 120 mg) of pantoprazole sodium injection were assessed in a single-dose, open-label, placebo-controlled, dose-response study. The results of this study are shown in Table 3. Healthy subjects received a continuous infusion for 25 hours of pentagastrin (PG) at 1 mcg/kg/h, a dose known to produce submaximal gastric acid secretion.

The placebo group showed a sustained, continuous acid output for 25 hours, validating the reliability of the testing model. Pantoprazole sodium injection had an onset of antisecretory activity within 15 to 30 minutes of administration. Doses of 20 to 80 mg of pantoprazole sodium injection substantially reduced the 24-hour cumulative PSAO in a dose-dependent manner, despite a short plasma elimination half-life.

Complete suppression of PSAO was achieved with 80 mg within approximately 2 hours and no further significant suppression was seen with 120 mg. The duration of action of pantoprazole sodium injection was 24 hours. Table 3.

Gastric Acid Output (mEq/hr, Mean ± SD) and Percent Inhibition Compared to individual subject baseline prior to treatment with pantoprazole sodium injection. NA = not applicable. (Mean ± SD) of Pentagastrin-Stimulated Acid Output Over 24 Hours Following a Single Dose of Pantoprazole Sodium Injection Inhibition of gastric acid output and the percent inhibition of stimulated acid output in response to pantoprazole sodium injection may be higher after repeated doses. in Healthy Subjects Treatment Dose 2 hours 4 hours 12 hours 24 hours Acid Output % Inhibition Acid Output % Inhibition Acid Output % Inhibition Acid Output % Inhibition 0 mg (Placebo, n=4) 39 ± 21 NA 26 ± 14 NA 32 ± 20 NA 38 ± 24 NA 20 mg (n=4-6) 13 ± 18 47 ± 27 6 ± 8 83 ± 21 20 ± 20 54 ± 44 30 ± 23 45 ± 43 40 mg (n=8) 5 ± 5 82 ± 11 4 ± 4 90 ± 11 11 ± 10 81 ± 13 16 ± 12 52 ± 36 80 mg (n=8) 0.1 ± 0.2 96 ± 6 0.3 ± 0.4 99 ± 1 2 ± 2 90 ± 7 7 ± 4 63 ± 18 In one study of gastric pH in healthy subjects, pantoprazole sodium was administered orally (40 mg enteric coated tablets) or pantoprazole sodium injection (40 mg) once daily for 5 days and pH was measured for 24 hours following the fifth dose.

The outcome measure was median percent of time that pH was ≥4 and the results were similar for intravenous and oral medications; however, the clinical significance of this parameter is unknown. Serum Gastrin Effects Serum gastrin concentrations were assessed in two placebo-controlled studies. In a 5-day study of oral pantoprazole with 40 and 60 mg doses in healthy subjects, following the last dose on day 5, median 24-hour serum gastrin concentrations were elevated by 3- to 4-fold compared to placebo in both 40 and 60 mg dose groups.

However, by 24 hours following the last dose, median serum gastrin concentrations for both groups returned to normal levels. In another placebo-controlled, 7-day study of 40 mg intravenous or oral pantoprazole in patients with GERD and a history of EE, the mean serum gastrin concentration increased approximately 50% from baseline and as compared with placebo, but remained within the normal range. During 6 days of repeated administration of pantoprazole sodium injection in patients with ZE Syndrome, consistent changes of serum gastrin concentrations from baseline were not observed.

Enterochromaffin-Like (ECL) Cell Effects There are no data available on the effects of intravenous pantoprazole sodium on ECL cells. In a nonclinical study in Sprague-Dawley rats, lifetime exposure (24 months) to oral 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 result from chronic elevation of serum gastrin concentrations.

The high density of ECL cells in the rat stomach makes this species highly susceptible to the proliferat… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis A multicenter, double-blind, two-period placebo-controlled study was conducted to assess the ability of pantoprazole sodium injection to maintain gastric acid suppression in patients switched from pantoprazole delayed-release tablets to pantoprazole sodium injection GERD patients (n=65, 26 to 64 years; 35 female; 9 Black, 11 Hispanic, 44 White, 1 other) with a history of EE were randomized to receive either 20 or 40 mg of oral pantoprazole once per day for 10 days (period 1), and then were switched in period 2 to either daily pantoprazole sodium injection or placebo for 7 days, matching their respective dose level from period 1.

Patients were administered all test medication with a light meal. Maximum acid output (MAO) and basal acid output (BAO) were determined 24 hours following the last day of oral medication (day 10), the first day (day 1) of intravenous administration and the last day of intravenous administration (day 7). MAO was estimated from a 1 hour continuous collection of gastric contents following subcutaneous injection of 6.0 mcg/kg of pentagastrin.

This study demonstrated that, after 10 days of repeated oral administration followed by 7 days of intravenous administration, the oral and intravenous dosage forms of pantoprazole 40 mg are similar in their ability to suppress MAO and BAO in patients with GERD and a history of EE (see Table 4 ). Also, patients on oral pantoprazole who were switched to intravenous placebo experienced a significant increase in acid output within 48 hours of their last oral dose (see Table 4). However, at 48 hours after their last oral dose, patients treated with pantoprazole sodium injection had a significantly lower mean basal acid output (see Table 4 ) than those treated with placebo.

Table 4. Antisecretory Effects (mEq/h) of 40 mg Pantoprazole Sodium Injection and 40 mg Pantoprazole Delayed-Release Tablets in GERD Patients with a History of EE Parameter P antoprazole Delayed-Release Tablets DAY 10 Pantoprazole Sodium for Injection DAY 7 Intravenous Placebo DAY 7 Mean maximum acid output 6.49 n=30 6.62 n=23 29.19 p<0.0001 Significantly different from pantoprazole sodium injection n=7 Mean basal acid output 0.80 n=30 0.53 n=23 4.14 n=7 To evaluate the effectiveness of pantoprazole sodium injection as an initial treatment to suppress gastric acid secretion, two studies were conducted.

Study 1 was a multicenter, double-blind, placebo-controlled, study of the pharmacodynamic effects of pantoprazole sodium injection and pantoprazole delayed-release tablets. Patients with GERD and a history of EE (n=78, 20 to 67 years; 39 females; 7 Black, 19 Hispanic, 52 White) were randomized to receive either 40 mg pantoprazole sodium injection, 40 mg pantoprazole delayed-release tablets, or placebo once daily for 7 days. Following an overnight fast, test medication was administered and patients were given a light meal within 15 minutes.

MAO and BAO were determined 24 hours following the last day of study medication. MAO was estimated from a 1 hour continuous collection of gastric contents following subcutaneous injection of 6.0 mcg/kg of pentagastrin to stimulate acid secretion. This study demonstrated that, after treatment for 7 days, patients treated with pantoprazole sodium injection had a significantly lower MAO and BAO than those treated with placebo (p<0.001), and results were comparable to those of patients treated with pantoprazole delayed-release tablets (see Table 5 ).

Table 5. Antisecretory Effects (mEq/h) of Initial Treatment with 40 mg Pantoprazole Sodium Injection and 40 mg Pantoprazole Delayed-Release Tablets in GERD Patients with a History of EE Parameter Pantoprazole Sodium for Injection DAY 7 Pantoprazole Delayed-Release Tablets DAY 7 Placebo DAY 7 Maximum acid output (mean ± SD) 8.4 ± 5.9 n=25 6.3 ± 6.6 n=22 20.9 ± 14.5 p<0.001 Significantly different from pantoprazole sodi… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50-kg person dosed at 40 mg/day. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas.

Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.

In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with pantoprazole doses of 5 to 50 mg/kg/day, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.

In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with pantoprazole doses of 5 to 150 mg/kg/day, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric fundic ECL cell hyperplasia.

A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive. Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay.

Pantoprazole was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay. There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with pantoprazole doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50-kg person dosed at 40 mg/day. In the gastric fundus, treatment with 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas.

Rare gastrointestinal tumors associated with pantoprazole treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment with 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.

In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with pantoprazole doses of 5 to 50 mg/kg/day, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of pantoprazole.

In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with pantoprazole doses of 5 to 150 mg/kg/day, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric fundic ECL cell hyperplasia.

A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive. Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay.

Pantoprazole was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay. There were no effects on fertility or reproductive performance when pantoprazole was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-9644-12 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* For Intravenous Infusion Only 100 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F.

Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw. Do not refreeze the thawed solution.

Thawed solution is expected to range from colorless to yellow over time. Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3571 PL 2040 Plastic Product of USA 07-34-00-1222 BAR CODE POSITION ONLY UPC-A XXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration. Do not force thaw.

Do not refreeze the thawed solution. Handle frozen product containers with care. Product containers may be fragile in the frozen state.

40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/100 mL (0.4 mg/mL)* Contains 6 units of Single-Dose bags. Each bag contains 100 mL. Store frozen at or below -20°C /-4°F.

Baxter Logo Rx only *FOR BAR CODE POSITION ONLY (01) 0000000000000 (10)XX000000 (21) 000000000000 (17)000000 NDC 0338-9644-12 Code 2G3571 *FOR BAR CODE POSITION ONLY (01) XXXXXXXXXXXXXX *Each 100 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 155 mg histidine, USP; 900 mg sodium chloride, USP; and water for injection, USP. Usual Dosage: See prescribing information. Baxter Healthcare Corporation, Deerfield, IL 60015 USA PL 2040 Plastic 07-04-00-0582 Container Label NDC 0338-9646-24 40 mg TOTAL Pantoprazole Sodium in 0.9% Sodium Chloride Injection 40 mg/50 mL (0.8 mg/mL)* For Intravenous Infusion Only 50 mL Single-Dose GALAXY Container Discard Unused Portion Rx only Sterile *Each 50 mL contains: 40 mg of pantoprazole (equivalent to 45.1 mg of pantoprazole sodium USP); 1 mg edetate disodium, USP; 77.5 mg histidine, USP; 450 mg sodium chloride, USP; and water for injection, USP.

Usual Dosage: See prescribing information. Store frozen at or below -20°C /-4°F. Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refrigeration.

Do not force thaw. Do not refreeze the thawed solution. Thawed solution is expected to range from colorless to yellow over time.

Do not add supplemental medication or additives. Baxter Logo Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA Code 2G3569 PL 2040 Plastic Product of USA 07-34-00-1221 *BAR CODE FOR POSITION ONLY (1) XXXXXXXXXXXXXX Carton Label Store frozen at or below -20°C /-4°F.

Thaw at room temperature 20-25°C (68 - 77°F) or under refrigeration 2-8°C (36 - 46°F) and store thawed solution as follows: - Refrigerated Storage: Use within 21 days - Room Temperature Storage: Use within 48 hours Protect from light when stored frozen or under refr… [Excerpted — this section continues on DailyMed.]

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

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

Medicare Part D (outpatient prescription) spending for 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 (this brand).

Top reported reactions

Fatigue20,774
Nausea17,856
Diarrhoea17,557
Dyspnoea17,287
Pain15,532
Headache13,322
Vomiting12,781

Age at onset

Neonate271
Infant49
Child214
Adolescent251
Adult23,758
Elderly25,724

Reporter sex

251,646 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization116,362
Death28,519
Life-threatening18,480
Disabling10,304
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25,002 0
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Company 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2472 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00338-9647-12 · Baxter 00338-9649-75 · Baxter →
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.