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Rabeprazole Sodium 20 mg Tablet, Delayed Release, 30-count — NDC 63187-0259-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rabeprazole Sodium 20 mg Tablet, Delayed Release, 30-count — NDC 63187-259-30 (Billing 63187-0259-30)

by Proficient Rx LP · 30 TABLET, DELAYED RELEASE in 1 BOTTLE

This is a package of 30 tablets of Rabeprazole Sodium 20 mg Tablet, Delayed Release from Proficient Rx LP, marketed since Nov 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 63187-0259-30
🏷️ FDA NDC (as labeled) 63187-259-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.3379/unit — full pricing hub ↓
Main listing for product 63187-259 · Also comes in: 60 tablets 63187-259-60
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-259-30
Product NDC 63187-259
11-digit billing NDC 63187025930
NCPDP billing unit EA — each (per item)
RxCUI 854868
UNII 3L36P16U4R
UPC 0363187259303
Application # ANDA090678
SPL Set ID 14412af6-e99c-4264-bc34-28a6f139f252
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 2013-11-08
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance RABEPRAZOLE SODIUM
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49270076100620
GPI class RABEprazole Sodium
GCN Seq No 040941
GCN 94639
HICL code 018847
Ingredient (HICL) Rabeprazole 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 RABEPRAZOLE SOD DR 20 MG TAB
FDB brand name Rabeprazole Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 040941
  • GCN: 94639
  • GPI-14 (Medi-Span): 49270076100620
  • HICL (First Databank): 018847
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 854868
Why two NDCs? The FDA registers this code as 63187-259-30 — 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 → 63187-0259-30. 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.

Clinical

Label name RABEPRAZOLE SOD DR 20 MG TAB Ingredient Rabeprazole Sodium
📖 What it is MedlinePlus · NLM

Rabeprazole is used to treat the symptoms of 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 that connects the throat and stomach) in adults and children 12 year of age and older. Rabeprazole is used to treat damage from GERD, allow the esophagus to heal, and prevent further damage to the esophagus in adults. Rabeprazole is also used to treat conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Rabeprazole is used to treat ulcers (...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Doctors use it for GERD, duodenal ulcers, H. pylori infection with duodenal ulcer disease, and conditions with too much stomach acid like Zollinger-Ellison...
  • Swallow the tablet whole. Don’t chew, crush or split it. For most uses, food doesn’t matter. For duodenal ulcers, take it after a meal. For H. pylori, take it with food, twice a da...
  • The AcipHex label says to take it as soon as you remember. If it’s almost time for your next dose, skip the missed one. Never take two doses together.
  • Most are mild, like pain, sore throat, gas or constipation. Teens may get headache, nausea or diarrhea. Call me or your doctor if you have severe or lasting diarrhea, a bad rash or...
📖 Read our full Rabeprazole guide →
9
Nutrient depletion considerations

Rabeprazole Sodium may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Rabeprazole Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3379 $10.14 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0259-30 You're viewing this Main listing 30 TABLET, DELAYED RELEASE in 1 BOTTLE 2019-01-01 — Active
63187-0259-60 63187-259-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE 2019-01-01 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, delayed release in 1 bottle.
How does this package differ from NDC 63187-0259-60?
Both are Rabeprazole Sodium 20 mg Tablet, Delayed Release — the drug itself is identical. This page's package is the 30-count one, while NDC 63187-0259-60 is the 60 tablets package.
What NDC number is used to bill for this package of Rabeprazole Sodium 20 mg Tablet, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rabeprazole Sodium 20 mg 62135-0503-30 Chartwell 30 tablets $0.224 AB Availability likely —
Rabeprazole Sodium 20 mg 62175-0302-32 Lannett 30 tablets $0.224 AB Availability likely —
Rabeprazole Sodium 20 mg 65862-0721-30 Aurobindo 30 tablets $0.224 — Availability likely —
Rabeprazole Sodium 20 mg 67877-0443-30 Ascend 30 tablets $0.224 AB Availability likely —
Rabeprazole Sodium 20 mg 72888-0059-30 Advagen 30 tablets $0.224 AB Availability likely —
Rabeprazole sodium 20 mg 13668-0107-05 Torrent 500 tablets $0.279 AB FDA listed —
Rabeprazole Sodium 20 mg 50090-4751-00 A-S 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 50090-6887-00 A-S 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 51407-0184-05 Golden 500 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 60760-0560-30 St. 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 60760-0972-30 St. 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mgthis 63187-0259-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole sodium 20 mg 63187-0555-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 65162-0724-03 Amneal 30 tablets — AB FDA listed —
Rabeprazole sodium 20 mg 68788-4060-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 68788-7459-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 68788-8536-03 Preferred 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 70518-2590-00 REMEDYREPACK 60 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 70518-3209-00 REMEDYREPACK 60 tablets — AB Discontinued —
Rabeprazole Sodium 20 mg 71205-0292-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71205-0603-30 Proficient 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-0244-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-1100-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-1558-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 71335-2304-02 Bryant 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72162-2367-05 Bryant 500 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72162-2503-03 Bryant 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72189-0142-90 DIRECT 90 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 72189-0169-30 DIRECT 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0107-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0223-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 76420-0818-30 Asclemed 30 tablets — AB FDA listed —
Rabeprazole Sodium DR 20 mg 80425-0094-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium DR 20 mg 80425-0134-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 80425-0363-01 Advanced 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 80425-0449-01 Advanced 30 tablets — AB FDA listed —
Aciphex 20 mg 80725-0243-30 Waylis 30 tablets — AB FDA listed —
Rabeprazole Sodium 20 mg 85509-1443-03 PHOENIX 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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.

What it looks like

Color Blue
ShapeRound
ImprintKU;7
Size7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerProficient Rx LP
Application holderLANNETT CO INC
FDA applicationANDA090678 (ANDA)
Labeler code63187
First marketedNov 2013
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Rabeprazole Sodium Delayed-Release Tablets is a proton pump inhibitor (PPI) indicated in adults for: • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)( 1.1 ) • Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ) • Treatment of Symptomatic GERD ( 1.3 ) • Healing of Duodenal Ulcers ( 1.4 ) • Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.5 ) • Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ) In adolescent patients 12 years of age and older for: • Short-term treatment of Symptomatic GERD ( 1.7 )

1.1Healing of Erosive or Ulcerative GERD in Adults Rabeprazole Sodium Delayed-Release Tablets is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sodium Delayed-Release Tablets may be considered.

1.2Maintenance of Healing of Erosive or Ulcerative GERD in Adults Rabeprazole Sodium Delayed-Release Tablets is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.

1.3Treatment of Symptomatic GERD in Adults Rabeprazole Sodium Delayed-Release Tablets is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults.

1.4Healing of Duodenal Ulcers in Adults Rabeprazole Sodium Delayed-Release Tablets is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

1.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults Rabeprazole Sodium Delayed-Release Tablets in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Clinical Studies (14.5) and Dosage and Administration (2.5) ].

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [ see Clinical Pharmacology (12.2) and the clarithromycin package insert, Clinical Pharmacology (12.2) ].

1.6Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults Rabeprazole Sodium Delayed-Release Tablets is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

1.7Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older Rabeprazole Sodium Delayed-Release Tablets is indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Rabeprazole Sodium Delayed-Release Tablets should be swallowed whole. The tablets should not be chewed, crushed, or split ( 2.10 ). Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 2.1 ) 20 mg once daily Maintenance of Healing of Erosive or Ulcerative GERD ( 2.2 ) 20 mg once daily Treatment of Symptomatic GERD in Adults ( 2.3 ) 20 mg once daily Healing of Duodenal Ulcers ( 2.4 ) 20 mg once daily after morning meal Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 2.5 ) Three Drug Regimen: Rabeprazole Sodium Delayed-Release Tablets 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg All three medications should be taken twice daily with morning and evening meals for 7 days Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 2.6 ) Starting dose 60 mg once daily then adjust to patient needs Treatment of Symptomatic GERD in Adolescents 12 Years of Age and Older ( 2.7 ) 20 mg once daily

2.1Healing of Erosive or Ulcerative GERD in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily for four to eight weeks [ see Indications and Usage (1.1) ]. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sodium Delayed-Release Tablets may be considered.

2.2Maintenance of Healing of Erosive or Ulcerative GERD in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily [ see Indications and Usage (1.2) ].

2.3Treatment of Symptomatic GERD in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily for 4 weeks [ see Indications and Usage (1.3) ]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. The recommended adolescent dosing is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily for 8 weeks.

2.4Healing of Duodenal Ulcers in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily after the morning meal for a period up to four weeks [ see Indications and Usage (1.4) ]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

2.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults TABLE 1 THREE DRUG REGIMEN It is important that patients comply with the full 7-day regimen [ see Clinical Studies (14.5) ]. All three medications should be taken twice daily with the morning and evening meals. Rabeprazole Sodium Delayed-Release Tablet 20 mg Twice Daily for 7 Days Amoxicillin 1000 mg Twice Daily for 7 Days Clarithromycin 500 mg Twice Daily for 7 Days

2.6Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults The dosage of Rabeprazole Sodium Delayed-Release Tablets in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated.

Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with Rabeprazole Sodium Delayed-Release Tablets for up to one year.

2.7Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks [ see Use in Specific Populations (8.4) and Clinical Studies (14.7) ].

2.9Elderly, Renal and Hepatic Impaired Patients No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 23 words ▾

3 DOSAGE FORMS AND STRENGTHS Rabeprazole Sodium Delayed-Release Tablets are provided in strength of 20 mg. Delayed-Release Tablets: 20 mg ( 3 )

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Rabeprazole Sodium Delayed-Release Tablets, refer to the Contraindications section of their package inserts. • History of hypersensitivity to rabeprazole ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy ( 5.1 ) • Use with warfarin: monitor for increases in INR and prothrombin time ( 5.2 ) • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea ( 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 ) • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs ( 5.5 )

5.1Presence of Gastric Malignancy Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Patients with healed GERD were treated for up to 40 months with rabeprazole and monitored with serial gastric biopsies. Patients without H. pylori infection (221 of 326 patients) had no clinically important pathologic changes in the gastric mucosa.

Patients with H. pylori infection at baseline (105 of 326 patients) had mild or moderate inflammation in the gastric body or mild inflammation in the gastric antrum. Patients with mild grades of infection or inflammation in the gastric body tended to change to moderate, whereas those graded moderate at baseline tended to remain stable. Patients with mild grades of infection or inflammation in the gastric antrum tended to remain stable.

At baseline 8% of patients had atrophy of glands in the gastric body and 15% had atrophy in the gastric antrum. At endpoint, 15% of patients had atrophy of glands in the gastric body and 11% had atrophy in the gastric antrum. Approximately 4% of patients had intestinal metaplasia at some point during follow-up, but no consistent changes were seen.

5.2Concomitant Use with Warfarin Steady state interactions of rabeprazole and warfarin have not been adequately evaluated in patients. There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Patients treated with a proton pump inhibitor and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

5.3Clostridium difficile Associated Diarrhea Published observational studies suggest that PPI therapy like Rabeprazole Sodium Delayed-Release Tablets 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.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Rabeprazole Sodium Delayed-Release Tablets , refer to Warnings and Precautions sections of those package inserts.

5.4Bone Fracture Several published observational studies in adults 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) ].

5.5Hypomagnesemia Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizur… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Worldwide, over 2900 patients have been treated with rabeprazole in Phase II-III clinical trials involving various dosages and durations of treatment. Because clinical trials are conducted under 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 practice. • In the adult studies (4 to 8 weeks), adverse reactions that occurred at a rate greater than 2% and greater than placebo included pain, pharyngitis, flatulence, infection and constipation ( 6.1 ). • In studies of adolescent patients (ages 12 to 16 years, and up to 36 weeks exposure) adverse reactions that occurred at a rate of ≥5% of patients included abdominal pain, diarrhea and headache ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Adults The data described below reflect exposure to Rabeprazole Sodium Delayed-Release Tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo- and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female.

The racial distribution was 86% Caucasian, 8% African American, 2% Asian and 5% other. Most patients received either 10 mg, 20 mg or 40 mg/day of Rabeprazole Sodium Delayed-Release Tablets. An analysis of adverse reactions appearing in ³ 2% of Rabeprazole Sodium Delayed-Release Tablet patients (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs.

1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs.

1%), and constipation (2% vs. 1%). Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to rabeprazole for 6 months while at least 33% were exposed for 12 months.

Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of Rabeprazole Sodium Delayed-Release Tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole. The safety profile of rabeprazole in the maintenance studies in adults was consistent with what was observed in the acute studies. Other adverse reactions that were seen in controlled clinical trials, which do not meet the above criteria (≥ 2% of Rabeprazole Sodium Delayed-Release Tablets treated patients and greater than placebo) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.

Combination Treatment with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively. No clinically significant laboratory abnormalities particular to the drug combinations were observed.

For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective package prescribing information, Adverse Reactions section. Pediatric In a multicenter, open-label study of adolescent patients aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The ad… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Increased INR and prothrombin times have been reported with concomitant use with warfarin. Patients need to be monitored ( 7.2 ) • Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro ( 7.3 ) • Rabeprazole Sodium Delayed-Release Tablets inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin) ( 7.4 ) • Rabeprazole Sodium Delayed-Release Tablets may reduce the plasma levels of atazanavir ( 7.4 ) • Methotrexate: Rabeprazole Sodium Delayed-Release Tablets may increase serum level of methotrexate ( 7.7 )

7.1Drugs Metabolized by CYP450 Rabeprazole is metabolized by the cytochrome P450 (CYP450) drug metabolizing enzyme system. Studies in healthy subjects have shown that rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP450 system, such as warfarin and theophylline given as single oral doses, diazepam as a single intravenous dose, and phenytoin given as a single intravenous dose (with supplemental oral dosing). Steady state interactions of rabeprazole and other drugs metabolized by this enzyme system have not been studied in patients.

7.2Warfarin There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including rabeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death [ see Warnings and Precautions (5.2) ].

7.3Cyclosporine In vitro incubations employing human liver microsomes indicated that rabeprazole inhibited cyclosporine metabolism with an IC 50 of 62 micromolar, a concentration that is over 50 times higher than the C max in healthy volunteers following 14 days of dosing with 20 mg of rabeprazole. This degree of inhibition is similar to that by omeprazole at equivalent concentrations.

7.4Compounds Dependent on Gastric pH for Absorption Rabeprazole produces sustained inhibition of gastric acid secretion. An interaction with compounds which are dependent on gastric pH for absorption may occur due to the magnitude of acid suppression observed with rabeprazole. For example, in normal subjects, co-administration of rabeprazole 20 mg QD resulted in an approximately 30% decrease in the bioavailability of ketoconazole and increases in the AUC and C max for digoxin of 19% and 29%, respectively.

Therefore, patients may need to be monitored when such drugs are taken concomitantly with rabeprazole. Co-administration of rabeprazole and antacids produced no clinically relevant changes in plasma rabeprazole concentrations. Concomitant use of atazanavir and proton pump inhibitors is not recommended.

Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.

7.5Drugs Metabolized by CYP2C19 In a clinical study in Japan evaluating rabeprazole in adult patients categorized by CYP2C19 genotype (n=6 per genotype category), gastric acid suppression was higher in poor metabolizers as compared to extensive metabolizers. This could be due to higher rabeprazole plasma levels in poor metabolizers. Whether or not interactions of rabeprazole sodium with other drugs metabolized by CYP2C19 would be different between extensive metabolizers and poor metabolizers has not been studied.

7.6Combined Administration with Clarithromycin Combined administration consisting of rabeprazole, amoxicillin, and clarithromycin resulted in increases in plasma concentrations of rabeprazole and 14-hydroxyclarithromycin [ see Clinical Pharmacology (12.3) ]. Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [ see Warnings and Precautions in prescribing information for clarithromycin ]. Because of these drug interactions, clarithromycin is contraindicated for… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • The safety and efficacy of Rabeprazole Sodium Delayed-Release Tablets for GERD have not been established for pediatric patients less than 12 years of age ( 8.4 ). • The safety and efficacy of Rabeprazole Sodium Delayed-Release Tablets for the other adult indications have not been established for pediatric patients ( 8.4 ).

8.1Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with Rabeprazole Sodium Delayed-Release Tablets in pregnant women. No evidence of teratogenicity was seen in animal reproduction studies with rabeprazole at 13 and 8 times the human exposure at the recommended dose for GERD, in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data Embryo-fetal developmental studies have been performed in rats at intravenous doses of rabeprazole up to 50 mg/kg/day (plasma AUC of 11.8 µg∙hr/mL, about 13 times the human exposure at the recommended oral dose for GERD) and rabbits at intravenous doses up to 30 mg/kg/day (plasma AUC of 7.3 µg∙hr/mL, about 8 times the human exposure at the recommended oral dose for GERD) and have revealed no evidence of harm to the fetus due to rabeprazole. Administration of rabeprazole to rats in late gestation and during lactation at an oral dose of 400 mg/kg/day (about 195-times the human oral dose based on mg/m 2 ) resulted in decreases in body weight gain of the pups.

8.3Nursing Mothers It is not known if Rabeprazole Sodium Delayed-Release Tablets is excreted in human milk; however, rabeprazole is present in rat milk. Because many drugs are excreted in milk, caution should be exercised when Rabeprazole Sodium Delayed-Release Tablets is administered to a nursing woman.

8.4Pediatric Use Symptomatic GERD in Adolescent Patients Greater or Equal to 12 Years of Age In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD, or suspected or endoscopically proven GERD were randomized and treated with either Rabeprazole Sodium 10 mg or Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy. The adverse event profile in adolescent patients was similar to that of adults.

The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in these studies that were not previously observed in adults.

8.5Geriatric Use Of the total number of subjects in clinical studies of Rabeprazole Sodium Delayed-Release Tablets, 19% were 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Gender Duodenal ulcer and erosive esophagitis healing rates in women are similar to those in men. Adverse reactions and laboratory test abnormalities in women occurred at rates similar to those in men.

🤰 Pregnancy 191 words ▾

8.1Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with Rabeprazole Sodium Delayed-Release Tablets in pregnant women. No evidence of teratogenicity was seen in animal reproduction studies with rabeprazole at 13 and 8 times the human exposure at the recommended dose for GERD, in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data Embryo-fetal developmental studies have been performed in rats at intravenous doses of rabeprazole up to 50 mg/kg/day (plasma AUC of 11.8 µg∙hr/mL, about 13 times the human exposure at the recommended oral dose for GERD) and rabbits at intravenous doses up to 30 mg/kg/day (plasma AUC of 7.3 µg∙hr/mL, about 8 times the human exposure at the recommended oral dose for GERD) and have revealed no evidence of harm to the fetus due to rabeprazole. Administration of rabeprazole to rats in late gestation and during lactation at an oral dose of 400 mg/kg/day (about 195-times the human oral dose based on mg/m 2 ) resulted in decreases in body weight gain of the pups.

🧒 Pediatric Use 122 words ▾

8.4Pediatric Use Symptomatic GERD in Adolescent Patients Greater or Equal to 12 Years of Age In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD, or suspected or endoscopically proven GERD were randomized and treated with either Rabeprazole Sodium 10 mg or Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy. The adverse event profile in adolescent patients was similar to that of adults.

The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in these studies that were not previously observed in adults.

🧓 Geriatric Use 73 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of Rabeprazole Sodium Delayed-Release Tablets, 19% were 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 175 words ▾

10 OVERDOSAGE Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. There has been no experience with large overdoses with rabeprazole. Seven reports of accidental overdosage with rabeprazole have been received.

The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole QD.

No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.

Single oral doses of rabeprazole at 786 mg/kg and 1024 mg/kg were lethal to mice and rats, respectively. The single oral dose of 2000 mg/kg was not lethal to dogs. The major symptoms of acute toxicity were hypoactivity, labored respiration, lateral or prone position and convulsion in mice and rats and watery diarrhea, tremor, convulsion and coma in dogs.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.

In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro , rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds.

12.2Pharmacodynamics Antisecretory Activity The antisecretory effect begins within one hour after oral administration of 20 mg Rabeprazole Sodium Delayed-Release Tablets. The median inhibitory effect of Rabeprazole Sodium Delayed-Release Tablets on 24 hour gastric acidity is 88% of maximal after the first dose. Rabeprazole Sodium Delayed-Release Tablets 20 mg inhibits basal and peptone meal-stimulated acid secretion versus placebo by 86% and 95%, respectively, and increases the percent of a 24-hour period that the gastric pH>3 from 10% to 65% (see table below).

This relatively prolonged pharmacodynamic action compared to the short pharmacokinetic half-life (1-2 hours) reflects the sustained inactivation of the H + , K + ATPase. TABLE 3 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS VERSUS PLACEBO AFTER 7 DAYS OF ONCE DAILY DOSING Parameter Rabeprazole Sodium Delayed-Release Tablets (20 mg QD) Placebo Basal Acid Output (mmol/hr) 0.4 (p>0.01 versus placebo)

2.8Stimulated Acid Output (mmol/hr) 0.6 13.3 % Time Gastric pH>3 65 10 Compared to placebo, Rabeprazole Sodium Delayed-Release Tablets, 10 mg, 20 mg, and 40 mg, administered once daily for 7 days significantly decreased intragastric acidity with all doses for each of four meal-related intervals and the 24-hour time period overall. In this study, there were no statistically significant differences between doses; however, there was a significant dose-related decrease in intragastric acidity. The ability of rabeprazole to cause a dose-related decrease in mean intragastric acidity is illustrated below.

TABLE 4 AUC ACIDITY (MMOL∙HR/L) RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS VERSUS PLACEBO ON DAY 7 OF ONCE DAILY DOSING (MEAN±SD) Treatment AUC interval (hrs) 10 mg RBP (N=24) 20 mg RBP (N=24) 40 mg RBP (N=24) Placebo (N=24) 08:00 – 13:00 19.6±21.5 (p<0.001 versus placebo) 12.9±23 7.6±14.7 91.1±39.7 13:00 – 19:00 5.6±9.7 8.3±29.8 1.3±5.2 95.5±48.7 19:00 – 22:00 0.1±0.1 0.1±0.06 0.0±0.02 11.9±12.5 22:00 – 08:00 129.2±84 109.6±67.2 76.9±58.4 479.9±165 AUC 0-24 hours 155.5±90.6 130.9±81 85.8±64.3 678.5±216 After administration of 20 mg Rabeprazole Sodium Delayed-Release Tablets once daily for eight days, the mean percent of time that gastric pH>3 or gastric pH>4 after a single dose (Day 1) and multiple doses (Day 8) was significantly greater than placebo (see table below).

The decrease in gastric acidity and the increase in gastric pH observed with 20 mg Rabeprazole Sodium Delayed-Release Tablets administered once daily for eight days were compared to the same parameters for placebo, as illustrated below: TABLE 5 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS ONCE DAILY DOSING VERSUS PLACEBO ON DAY 1 AND DAY 8 Parameter Rabeprazole Sodium Delayed-Release Tablets 20 mg QD Placebo Day 1 Day8 Day 1 Day 8 Mean AUC 0-24 Acidity 340.8 (p<0.001 versus placebo) 176.9 925.5 862.4 Median trough pH (23-hr) No inferential statistics conducted for this parameter.

3.773.51 1.27 1.38 % Time Gastric pH>3 Gastric pH was measured every hour over a 24-hour period. 54.6 68.7 19.1 21.… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 131 words ▾

12.1Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion.

In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide. When studied in vitro , rabeprazole is chemically activated at pH 1.2 with a half-life of 78 seconds. It inhibits acid transport in porcine gastric vesicles with a half-life of 90 seconds.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rabeprazole Sodium Delayed-Release Tablets 20 mg is supplied as delayed-release blue enteric-coated round tablets debossed with "KU" on one side and "7" on the other. Bottles of 30 NDC 63187-259-30 Bottles of 60 NDC 63187-259-60 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [ see USP Controlled Room Temperature]. Protect from moisture.

📦 Storage and Handling 18 words ▾

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [ see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 160 words ▾

11 DESCRIPTION The active ingredient in Rabeprazole Sodium Delayed-Release Tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H- benzimidazole sodium salt. It has an empirical formula of C 18 H 20 N 3 NaO 3 S and a molecular weight of 381.42.

Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions.

The structural formula is: FIGURE 1 Rabeprazole Sodium Delayed-Release Tablets is available for oral administration as Delayed-Release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are crospovidone, FD&C Blue #1, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc and triethyl citrate. Figure 1

💬 Information for Patients 86 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Error! Hyperlink reference not valid. ). How to Take Rabeprazole Sodium Delayed-Release Tablets Patients should be cautioned that Rabeprazole Sodium Delayed-Release Tablets should be swallowed whole.

The tablets should not be chewed, crushed, or split. Rabeprazole Sodium Delayed-Release Tablets can be taken with or without food. Advise patients to immediately report and seek care for diarrhea that does not improve.

This may be a sign of Clostridium difficile associated diarrhea [ see Warnings and Precautions (5.3) ].

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Rabeprazole Sodium Delayed-Release Tablets CIA76375B Rev. 2E 10/2013 Read the Medication Guide that comes with Rabeprazole Sodium Delayed-Release Tablets before you start taking it and each time you get a refill. There may be new information.

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

Talk with your doctor. Rabeprazole Sodium Delayed-Release Tablets can cause serious side effects, including: • Diarrhea . Rabeprazole Sodium Delayed-Release Tablets may increase your risk of getting severe diarrhea.

This diarrhea may be caused by in 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 Proton Pump Inhibitor medicines for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

You should take Rabeprazole Sodium Delayed-Release Tablets 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 Rabeprazole Sodium Delayed-Release Tablets. Rabeprazole Sodium Delayed-Release Tablets can have other serious side effects.

See "What are the possible side effects of Rabeprazole Sodium Delayed-Release Tablets?" What is Rabeprazole Sodium Delayed-Release Tablets? Rabeprazole Sodium Delayed-Release Tablet is a prescription medicine called a proton pump inhibitor (PPI). Rabeprazole Sodium Delayed-Release Tablets reduces the amount of acid in your stomach.

Rabeprazole Sodium Delayed-Release Tablets is used in adults: • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain. If needed, your doctor may decide to prescribe another 8 weeks of Rabeprazole Sodium Delayed-Release Tablets. • to maintain the healing of the esophagus and relief of symptoms related to EE. It is not known if Rabeprazole Sodium Delayed-Release Tablets is safe and effective if used longer than 12 months (1 year). • for 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).

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 up to 4 weeks for the healing and relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach. • for 7 days with certain antibiotic medicines to treat an infection caused by bacteria called H. pylori.

Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back. • for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Rabeprazole Sodium Delayed-Release Tablets is used in adolescents 12 years of age and older: • for up to 8 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD). It is not known if Rabeprazole Sodium Delayed-Release Tablets is safe and effective in children under the age of 12. Who should not take Rabeprazole Sodium Delayed-Release Tablets?

Do not take Rabeprazole Sodium Delayed-Release Tablets if you: • are allergic to rabeprazole or any of the other ingredients in Rabeprazole Sodium Delayed-Release Tablets. See the end of this Medication Guide for a complete list of ingredients in Rabeprazole Sodium Delayed-Release… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 46 words ▾

8.3Nursing Mothers It is not known if Rabeprazole Sodium Delayed-Release Tablets is excreted in human milk; however, rabeprazole is present in rat milk. Because many drugs are excreted in milk, caution should be exercised when Rabeprazole Sodium Delayed-Release Tablets is administered to a nursing woman.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Rabeprazole Sodium Delayed-Release Tablets are enteric-coated to allow rabeprazole sodium, which is acid labile, to pass through the stomach relatively intact. After oral administration of 20 mg Rabeprazole Sodium Delayed-Release Tablets, peak plasma concentrations (C max ) of rabeprazole occur over a range of 2 to 5 hours (T max ). The rabeprazole C max and AUC are linear over an oral dose range of 10 mg to 40 mg.

There is no appreciable accumulation when doses of 10 mg to 40 mg are administered every 24 hours; the pharmacokinetics of rabeprazole is not altered by multiple dosing. Absorption : Absolute bioavailability for a 20 mg oral tablet of rabeprazole (compared to intravenous administration) is approximately 52%. When Rabeprazole Sodium Delayed-Release Tablets are administered with a high fat meal, T max is variable; which concomitant food intake may delay the absorption up to 4 hours or longer.

However, the C max and the extent of rabeprazole absorption (AUC) are not significantly altered. Thus Rabeprazole Sodium Delayed-Release Tablets may be taken without regard to timing of meals. Distribution : Rabeprazole is 96.3% bound to human plasma proteins.

Metabolism : Rabeprazole is extensively metabolized. A significant portion of rabeprazole is metabolized via systemic nonenzymatic reduction to a thioether compound. Rabeprazole is also metabolized to sulphone and desmethyl compounds via cytochrome P450 in the liver.

The thioether and sulphone are the primary metabolites measured in human plasma. These metabolites were not observed to have significant antisecretory activity. In vitro studies have demonstrated that rabeprazole is metabolized in the liver primarily by cytochromes P450 3A (CYP3A) to a sulphone metabolite and cytochrome P450 2C19 (CYP2C19) to desmethyl rabeprazole.

CYP2C19 exhibits a known genetic polymorphism due to its deficiency in some sub-populations (e.g. 3 to 5% of Caucasians and 17 to 20% of Asians). Rabeprazole metabolism is slow in these sub-populations, therefore, they are referred to as poor metabolizers of the drug.

Elimination : Following a single 20 mg oral dose of 14 C-labeled rabeprazole, approximately 90% of the drug was eliminated in the urine, primarily as thioether carboxylic acid; its glucuronide, and mercapturic acid metabolites. The remainder of the dose was recovered in the feces. Total recovery of radioactivity was 99.8%.

No unchanged rabeprazole was recovered in the urine or feces. Geriatric : In 20 healthy elderly subjects administered 20 mg rabeprazole tablet once daily for seven days, AUC values approximately doubled and the C max increased by 60% compared to values in a parallel younger control group. There was no evidence of drug accumulation after once daily administration [ see Use in Special Populations (8.5) ].

Pediatric : The pharmacokinetics of rabeprazole was studied in pediatric patients with GERD aged 12 to 16 years. Patients 12 to 16 Years of Age The pharmacokinetics of rabeprazole was studied in 12 adolescent patients with GERD 12 to 16 years of age, in a multicenter study. Patients received rabeprazole 20 mg tablets once daily for five or seven days.

An approximate 40% increase in exposure was noted following 5 to 7 days of dosing compared with the exposure after 1 day dosing. Pharmacokinetic parameters in adolescent patients with GERD 12 to 16 years of age were within the range observed in healthy adult volunteers. Gender and Race : In analyses adjusted for body mass and height, rabeprazole pharmacokinetics showed no clinically significant differences between male and female subjects.

In studies that used different formulations of rabeprazole, AUC 0-∞ values for healthy Japanese men were approximately 50-60% greater than values derived from pooled data from healthy men in the United States. Renal Disease : In 10 patients with stable end-stage renal disease requiring maintenance hemodialysis (creatinine clearance ≤5 mL/min/1.73 m 2 ), no clinical… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Antisecretory Activity The antisecretory effect begins within one hour after oral administration of 20 mg Rabeprazole Sodium Delayed-Release Tablets. The median inhibitory effect of Rabeprazole Sodium Delayed-Release Tablets on 24 hour gastric acidity is 88% of maximal after the first dose. Rabeprazole Sodium Delayed-Release Tablets 20 mg inhibits basal and peptone meal-stimulated acid secretion versus placebo by 86% and 95%, respectively, and increases the percent of a 24-hour period that the gastric pH>3 from 10% to 65% (see table below).

This relatively prolonged pharmacodynamic action compared to the short pharmacokinetic half-life (1-2 hours) reflects the sustained inactivation of the H + , K + ATPase. TABLE 3 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS VERSUS PLACEBO AFTER 7 DAYS OF ONCE DAILY DOSING Parameter Rabeprazole Sodium Delayed-Release Tablets (20 mg QD) Placebo Basal Acid Output (mmol/hr) 0.4 (p>0.01 versus placebo)

2.8Stimulated Acid Output (mmol/hr) 0.6 13.3 % Time Gastric pH>3 65 10 Compared to placebo, Rabeprazole Sodium Delayed-Release Tablets, 10 mg, 20 mg, and 40 mg, administered once daily for 7 days significantly decreased intragastric acidity with all doses for each of four meal-related intervals and the 24-hour time period overall. In this study, there were no statistically significant differences between doses; however, there was a significant dose-related decrease in intragastric acidity. The ability of rabeprazole to cause a dose-related decrease in mean intragastric acidity is illustrated below.

TABLE 4 AUC ACIDITY (MMOL∙HR/L) RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS VERSUS PLACEBO ON DAY 7 OF ONCE DAILY DOSING (MEAN±SD) Treatment AUC interval (hrs) 10 mg RBP (N=24) 20 mg RBP (N=24) 40 mg RBP (N=24) Placebo (N=24) 08:00 – 13:00 19.6±21.5 (p<0.001 versus placebo) 12.9±23 7.6±14.7 91.1±39.7 13:00 – 19:00 5.6±9.7 8.3±29.8 1.3±5.2 95.5±48.7 19:00 – 22:00 0.1±0.1 0.1±0.06 0.0±0.02 11.9±12.5 22:00 – 08:00 129.2±84 109.6±67.2 76.9±58.4 479.9±165 AUC 0-24 hours 155.5±90.6 130.9±81 85.8±64.3 678.5±216 After administration of 20 mg Rabeprazole Sodium Delayed-Release Tablets once daily for eight days, the mean percent of time that gastric pH>3 or gastric pH>4 after a single dose (Day 1) and multiple doses (Day 8) was significantly greater than placebo (see table below).

The decrease in gastric acidity and the increase in gastric pH observed with 20 mg Rabeprazole Sodium Delayed-Release Tablets administered once daily for eight days were compared to the same parameters for placebo, as illustrated below: TABLE 5 GASTRIC ACID PARAMETERS RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS ONCE DAILY DOSING VERSUS PLACEBO ON DAY 1 AND DAY 8 Parameter Rabeprazole Sodium Delayed-Release Tablets 20 mg QD Placebo Day 1 Day8 Day 1 Day 8 Mean AUC 0-24 Acidity 340.8 (p<0.001 versus placebo) 176.9 925.5 862.4 Median trough pH (23-hr) No inferential statistics conducted for this parameter.

3.773.51 1.27 1.38 % Time Gastric pH>3 Gastric pH was measured every hour over a 24-hour period. 54.6 68.7 19.1 21.7 % Time Gastric pH>4 44.1 60.3 7.6 11 Effects on Esophageal Acid Exposure In patients with gastroesophageal reflux disease (GERD) and moderate to severe esophageal acid exposure, Rabeprazole Sodium Delayed-Release 20 mg and 40 mg tablets per day decreased 24-hour esophageal acid exposure. After seven days of treatment, the percentage of time that esophageal pH<4 decreased from baselines of 24.7% for 20 mg and 23.7% for 40 mg, to 5.1% and 2%, respectively.

Normalization of 24-hour intraesophageal acid exposure was correlated to gastric pH>4 for at least 35% of the 24-hour period; this level was achieved in 90% of subjects receiving Rabeprazole Sodium Delayed-Release Tablets 20 mg and in 100% of subjects receiving Rabeprazole Sodium Delayed-Release Tablets 40 mg. With Rabeprazole Sodium Delayed-Release Tablets 20 mg and 40 mg per day, significant effects on gastric and esophageal pH w… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Healing of Erosive or Ulcerative GERD in Adults In a U.S., multicenter, randomized, double-blind, placebo-controlled study, 103 patients were treated for up to eight weeks with placebo, 10 mg, 20 mg or 40 mg Rabeprazole Sodium Delayed-Release Tablets QD. For this and all studies of GERD healing, only patients with GERD symptoms and at least grade 2 esophagitis (modified Hetzel-Dent grading scale) were eligible for entry. Endoscopic healing was defined as grade 0 or 1.

Each rabeprazole dose was significantly superior to placebo in producing endoscopic healing after four and eight weeks of treatment. The percentage of patients demonstrating endoscopic healing was as follows: TABLE 7 HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) PERCENTAGE OF PATIENTS HEALED Week 10 mg Rabeprazole Sodium Delayed-Release Tablets QD N=27 20 mg Rabeprazole Sodium Delayed-Release Tablets QD N=25 40 mg Rabeprazole Sodium Delayed-Release Tablets QD N=26 Placebo N=25 4 63% (p<0.001 versus placebo) 56% 54% 0% 8 93% 84% 85% 12% In addition, there was a statistically significant difference in favor of the Rabeprazole Sodium Delayed-Release Tablets 10 mg, 20 mg, and 40 mg doses compared to placebo at Weeks 4 and 8 regarding complete resolution of GERD heartburn frequency (p≤0.026).

All Rabeprazole Sodium Delayed-Release Tablets groups reported significantly greater rates of complete resolution of GERD daytime heartburn severity compared to placebo at Weeks 4 and 8 (p≤0.036). Mean reductions from baseline in daily antacid dose were statistically significant for all Rabeprazole Sodium Delayed-Release Tablets groups when compared to placebo at both Weeks 4 and 8 (p≤0.007). In a North American multicenter, randomized, double-blind, active-controlled study of 336 patients, Rabeprazole Sodium Delayed-Release Tablets was statistically superior to ranitidine with respect to the percentage of patients healed at endoscopy after four and eight weeks of treatment (see table below): TABLE 8 HEALING OF EROSIVE OR ULCERATIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) PERCENTAGE OF PATIENTS HEALED Week Rabeprazole Sodium Delayed-Release Tablets 20 mg QD N=167 Ranitidine 150 mg QID N=169 4 59% (p<0.001 versus ranitidine) 36% 8 87% 66% Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily was significantly more effective than ranitidine 150 mg QID in the percentage of patients with complete resolution of heartburn at Weeks 4 and 8 (p<0.001).

Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily was also more effective in complete resolution of daytime heartburn (p≤0.025), and nighttime heartburn (p≤0.012) at both Weeks 4 and 8, with significant differences by the end of the first week of the study.

14.2Long-term Maintenance of Healing of Erosive or Ulcerative GERD in Adults The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric antisecretory therapy was assessed in two U.S., multicenter, randomized, double-blind, placebo-controlled studies of identical design of 52 weeks duration. The two studies randomized 209 and 285 patients, respectively, to receive either 10 mg or 20 mg of Rabeprazole Sodium Delayed-Release Tablets QD or placebo. As demonstrated in the tables below, Rabeprazole Sodium Delayed-Release Tablets was significantly superior to placebo in both studies with respect to the maintenance of healing of GERD and the proportions of patients remaining free of heartburn symptoms at 52 weeks: TABLE 9 PERCENT OF PATIENTS IN ENDOSCOPIC REMISSION Rabeprazole Sodium Delayed-Release Tablets 10 mg Rabeprazole Sodium Delayed-Released Tablets 20 mg Placebo Study 1 N=66 N=67 N=70 Week 4 83% (p<0.001 versus placebo) 96% 44% Week 13 79% 93% 39% Week 26 77% 93% 31% Week 39 76% 91% 30% Week 52 73% 90% 29% Study 2 N=93 N=93 N=99 Week 4 89% 94% 40% Week 13 86% 91% 33% Week 26 85% 89% 30% Week 39 84% 88% 29% Week 52 77% 86% 29% COMBINED STUDIES N=159 N=160 N=169 Week 4 87… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL PHARMACOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 88/104-week carcinogenicity study in CD-1 mice, rabeprazole at oral doses up to 100 mg/kg/day did not produce any increased tumor occurrence. The highest tested dose produced a systemic exposure to rabeprazole (AUC) of 1.40 µg∙hr/mL which is 1.6 times the human exposure (plasma AUC 0-∞ = 0.88 µg∙hr/mL) at the recommended dose for GERD (20 mg/day). In a 28-week carcinogenicity study in p53 +/- transgenic mice, rabeprazole at oral doses of 20, 60, and 200 mg/kg/day did not cause an increase in the incidence rates of tumors but produced gastric mucosal hyperplasia at all doses.

The systemic exposure to rabeprazole at 200 mg/kg/day is about 17-24 times the human exposure at the recommended dose for GERD. In a 104-week carcinogenicity study in Sprague-Dawley rats, males were treated with oral doses of 5, 15, 30 and 60 mg/kg/day and females with 5, 15, 30, 60 and 120 mg/kg/day. Rabeprazole produced gastric enterochromaffin-like (ECL) cell hyperplasia in male and female rats and ECL cell carcinoid tumors in female rats at all doses including the lowest tested dose.

The lowest dose (5 mg/kg/day) produced a systemic exposure to rabeprazole (AUC) of about 0.1 µg∙hr/mL which is about 0.1 times the human exposure at the recommended dose for GERD. In male rats, no treatment related tumors were observed at doses up to 60 mg/kg/day producing a rabeprazole plasma exposure (AUC) of about 0.2 µg∙hr/mL (0.2 times the human exposure at the recommended dose for GERD). Rabeprazole was positive in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward gene mutation test and the mouse lymphoma cell (L5178Y/TK+/-) forward gene mutation test.

Its demethylated-metabolite was also positive in the Ames test. Rabeprazole was negative in the in vitro Chinese hamster lung cell chromosome aberration test, the in vivo mouse micronucleus test, and the in vivo and ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) tests. Rabeprazole at intravenous doses up to 30 mg/kg/day (plasma AUC of 8.8 µg∙hr/mL, about 10 times the human exposure at the recommended dose for GERD) was found to have no effect on fertility and reproductive performance of male and female rats.

13.2Animal Toxicology and/or Pharmacology Studies in juvenile and young adult rats and dogs were performed. In juvenile animal studies rabeprazole sodium was administered orally to rats for up to 5 weeks and to dogs for up to 13 weeks, each commencing on Day 7 postpartum and followed by a 13-week recovery period. Rats were dosed at 5, 25 or 150 mg/kg/day and dogs were dosed at 3, 10 or 30 mg/kg/day.

The data from these studies were comparable to those reported for young adult animals. Pharmacologically mediated changes, including increased serum gastrin levels and stomach changes, were observed at all dose levels in both rats and dogs. These observations were reversible over the 13-week recovery periods.

Although body weights and/or crown-rump lengths were minimally decreased during dosing, no effects on the development parameters were noted in either juvenile rats or dogs.

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 88/104-week carcinogenicity study in CD-1 mice, rabeprazole at oral doses up to 100 mg/kg/day did not produce any increased tumor occurrence. The highest tested dose produced a systemic exposure to rabeprazole (AUC) of 1.40 µg∙hr/mL which is 1.6 times the human exposure (plasma AUC 0-∞ = 0.88 µg∙hr/mL) at the recommended dose for GERD (20 mg/day). In a 28-week carcinogenicity study in p53 +/- transgenic mice, rabeprazole at oral doses of 20, 60, and 200 mg/kg/day did not cause an increase in the incidence rates of tumors but produced gastric mucosal hyperplasia at all doses.

The systemic exposure to rabeprazole at 200 mg/kg/day is about 17-24 times the human exposure at the recommended dose for GERD. In a 104-week carcinogenicity study in Sprague-Dawley rats, males were treated with oral doses of 5, 15, 30 and 60 mg/kg/day and females with 5, 15, 30, 60 and 120 mg/kg/day. Rabeprazole produced gastric enterochromaffin-like (ECL) cell hyperplasia in male and female rats and ECL cell carcinoid tumors in female rats at all doses including the lowest tested dose.

The lowest dose (5 mg/kg/day) produced a systemic exposure to rabeprazole (AUC) of about 0.1 µg∙hr/mL which is about 0.1 times the human exposure at the recommended dose for GERD. In male rats, no treatment related tumors were observed at doses up to 60 mg/kg/day producing a rabeprazole plasma exposure (AUC) of about 0.2 µg∙hr/mL (0.2 times the human exposure at the recommended dose for GERD). Rabeprazole was positive in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward gene mutation test and the mouse lymphoma cell (L5178Y/TK+/-) forward gene mutation test.

Its demethylated-metabolite was also positive in the Ames test. Rabeprazole was negative in the in vitro Chinese hamster lung cell chromosome aberration test, the in vivo mouse micronucleus test, and the in vivo and ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) tests. Rabeprazole at intravenous doses up to 30 mg/kg/day (plasma AUC of 8.8 µg∙hr/mL, about 10 times the human exposure at the recommended dose for GERD) was found to have no effect on fertility and reproductive performance of male and female rats.

📚 References 36 words ▾

15 REFERENCES 1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically -Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000.

📄 Recent Major Changes 30 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Clostridium difficile associated diarrhea ( 5.3 ) 10/2012 Warnings and Precautions, Concomitant use of Rabeprazole Sodium Delayed-Release Tablets with Methotrexate ( 5.6 ) 05/2012

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label Rabeprazole Sodium Delayed-Release Tablets 20 mg Rx Only PHARMACIST: Dispense the accompanying Medication Guide to each patient. 63187-259-30

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 Rabeprazole Sodium — the program that covers self-administered drugs. 5 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 Rabeprazole 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
$3.14M
Claims incl. refills
88.3K
Beneficiaries
67.1K
Spend / beneficiary
$46.86
Spend / claim
$35.61
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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Orange Book / therapeutic-equivalence data ✓ Available
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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?
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 tablets (63187-0259-60). Each has its own NDC and its own page — see the package list near the top of this page.
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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?
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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?
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