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Rabeprazole Sodium 20 mg Tablet, Delayed Release, 60-count — NDC 68788-7459-06 package photo

Rabeprazole Sodium 20 mg Tablet, Delayed Release, 60-count

by Preferred Pharmaceuticals, Inc. · 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7459-6)
NDC 68788-7459-06
🏷️ FDA NDC (as labeled) 68788-7459-6 billing pads the package segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.3379/unit — full pricing hub ↓
Also comes in: 30 tablets 68788-7459-03
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 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

FDA NDC (as labeled) 68788-7459-6
Product NDC 68788-7459
11-digit billing NDC 68788745906
NCPDP billing unit EA — each (per item)
RxCUI 854868
UNII 3L36P16U4R
Application # ANDA208644
SPL Set ID ac9266ed-a9b2-4e77-8607-393b5dcdd2b6
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 2018-04-27
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance RABEPRAZOLE SODIUM
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-7459-6 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68788-7459-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPreferred Pharmaceuticals, Inc.
Application holderALKEM LABORATORIES LTD
FDA applicationANDA208644 (ANDA)
Labeler code68788
First marketedApr 2018
Product typeHuman Prescription Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Rabeprazole cuts down the amount of acid your stomach produces — significantly. That lower acid level gives your esophagus or stomach lining time to heal if it's been damaged by ac...
  • What exactly is rabeprazole supposed to do for me?
  • For most uses, you can take rabeprazole with or without food — it's flexible. The main exceptions are duodenal ulcers, where you should take it after your morning meal, and the H....
  • Does it matter when I take my tablet — with food or on an empty stomach?
📖 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.

💊 What it looks like

Color Yellow
ShapeRound
Imprint20
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 5Z17386USF
    A food-derived fat used as an emulsifier and stabilizer. It helps blend oil and water-based ingredients together and keeps the medicine's texture consistent throughout its shelf life.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 8LDD2V82F5
    A plant-derived polymer that forms a protective coating around tablets or capsules. It delays release of the medication until it reaches the small intestine, protecting sensitive ingredients and improving how the body absorbs them.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price 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 $20.27 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rabeprazole Sodium 20 mg 62135-0503-30 Chartwell 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 62175-0302-32 Lannett 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 65862-0721-30 Aurobindo 30 tablets $0.209 — Availability likely —
Rabeprazole Sodium 20 mg 67877-0443-30 Ascend 30 tablets $0.209 AB Availability likely —
Rabeprazole Sodium 20 mg 72888-0059-30 Advagen 30 tablets $0.209 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 mg 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 mgthis 68788-7459-06 Preferred 60 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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

Medicare Part D (outpatient prescription) spending for 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68788-7459-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7459-3) 2019-12-27 Active
68788-7459-06 You're viewing this 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7459-6) 2019-12-27 Active

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

Pack size FAQ

What quantity is in NDC 68788-7459-06?
NDC 68788-7459-06 is a 60-count package — 60 tablet, delayed release in 1 bottle.
What is the difference between NDC 68788-7459-06 and NDC 68788-7459-03?
Both are Rabeprazole Sodium 20 mg Tablet, Delayed Release — the drug itself is identical. NDC 68788-7459-06 is the 60-count package, while NDC 68788-7459-03 is the 30 tablets package.
What NDC number is used to bill for this package of Rabeprazole Sodium 20 mg Tablet, Delayed Release?
Bill NDC 68788-7459-06 — the 11-digit billing format is 68788745906. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68788-7459-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68788-7459-06, written without dashes as 68788745906. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68788-7459-06, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals, Inc.; the middle segment (7459) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Preferred Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (68788-7459-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Preferred Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 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) (). · Maintenance of Healing of Erosive or Ulcerative GERD (). · Treatment of Symptomatic GERD (). · Healing of Duodenal Ulcers (). · Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence (). · Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (). In adolescent patients 12 years of age and older for: · Short-term Treatment of Symptomatic GERD ()

1.1Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are 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 are 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 are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.

1.4Healing of Duodenal Ulcers in Adults Rabeprazole sodium delayed-release tablets are 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, are 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. 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 [and the full prescribing information for clarithromycin].

1.6Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

1.7Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older Rabeprazole sodium delayed-release tablets are 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 Table 1 shows the recommended dosage of rabeprazole sodium delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of rabeprazole sodium delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.

Table 1: Recommended Dosage and Duration of Rabeprazole sodium delayed-release tablets in Adults and Adolescents 12 Years of Age and Older Indication Dosage of Rabeprazole sodium delayed-release tablets Treatment Duration Adults Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg once daily 4 to 8 weeks* Maintenance of Healing of Erosive or Ulcerative GERD 20 mg once daily Controlled studies do not extend beyond 12 months Symptomatic GERD in Adults 20 mg once daily Up to 4 weeks** Healing of Duodenal Ulcers 20 mg once daily after the morning meal Up to 4 weeks*** Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Rabeprazole Sodium Delayed-Release Tablets 20 mg Amoxicillin 1,000 mg Clarithromycin 500 mg Take all three medications twice daily with morning and evening meals; it is important that patients comply with the full 7-day regimen [see Clinical Studies ()] 7 days Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Starting dose 60 mg once daily then adjust to patient needs; some patients require divided doses Dosages of 100 mg once daily and 60 mg twice daily have been administered As long as clinically indicated Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year Adolescents 12 Years of Age and Older Symptomatic GERD 20 mg once daily Up to 8 weeks * 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. ** If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. *** Most patients heal within 4 weeks; some patients may require additional therapy to achieve healing.

Administration Instructions • Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush, or split tablets. • For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal. • For Helicobacter pylori eradication take rabeprazole sodium delayed-release tablets with food. • For all other indications rabeprazole sodium delayed-release tablets can be taken with or without food. • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule.

Do not take two doses at the same time. Indication Recommended Dosage (2) Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg once daily for 4 to 8 weeks Maintenance of Healing of Erosive or Ulcerative GERD* studied for 12 months 20 mg once daily* Symptomatic GERD in Adults 20 mg once daily for 4 weeks Healing of Duodenal Ulcers 20 mg once daily after morning meal for up to 4 weeks Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Three Drug Regimen: All three medications should be taken twice daily with morning and evening meals for 7 days Rabeprazole sodium delayed-release Tablets 20 mg Amoxicillin 1,000 mg Clarithromycin 500 mg Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Starting dose 60 mg once daily then adjust to patient needs Symptomatic GERD in Adolescents 12 Years of Age and Older 20 mg once daily for up to 8 weeks Administration Instructions ( 2 ): • Swallow Rabeprazole delayed-release tablets whole.

Do not chew, crush or split the tablets. • For the treatment of duodenal ulcers take Rabeprazole delayed-release tablets after a meal.…

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Rabeprazole Sodium Delayed-Release Tablets are provided in one strength, 20 mg. The tablets are yellow, round , biconvex, bevelled, coated tablets imprinted ‘20’ in black on one side. Delayed-Release Tablets: 20 mg ().

⛔ Contraindications 136 words ▾

4 CONTRAINDICATIONS • Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [ see Warnings and Precautions ), Adverse Reactions ( 6) ]. • PPIs, including rabeprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ()]. • 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. · Patients with a history of hypersensitivity to rabeprazole (). · PPIs, including Rabeprazole delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products (, ). · Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with Rabeprazole Delayed-Release Tablets ().

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gastric Malignancy: In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing (). • Use with Warfarin: Monitor for increases in INR and prothrombin time (, ). • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients (5.3). • Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk of ). • 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 ). • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutatneous adverse reactions or other signs of hypersensitivity and consider further evaluation ). • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous, new onset or exacerbation of existing disease; discontinue Rabeprazole delayed-release tablets and refer to specialist for evaluation ). • Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (5.8). • Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs ). • Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.

With high dose methotrexate administration, consider a temporary withdrawal of Rabeprazole delayed-release tablets (,). • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy ).

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with rabeprazole sodium delayed-release tablets 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.

5.2Interaction 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 rabeprazole sodium delayed-release tablets and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see ].

5.3Acute 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 rabeprazole sodium delayed-release tablets and evaluate patients with suspected acute TIN [see Contraindication )] .

5.4Clostridium 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 () ]. 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 table…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ()] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ()] • Bone Fracture [see Warnings and Precautions ()] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ()] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ()] • Fundic Gland Polyps [see )] • Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation (). • Most common adverse reactions in adolescents (≥2%) are headache, diarrhea, nausea, vomiting, and abdominal pain ().

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1- 877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience 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. Adults The data described below reflect exposure to rabeprazole sodium delayed-release tablets in 1,064 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 to 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 per day of rabeprazole sodium delayed-release tablets.

An analysis of adverse reactions appearing in ≥2% of patients treated with rabeprazole sodium delayed-release tablets (n=1,064) 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 sodium delayed-release tablets for 6 months and 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.

Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with rabeprazole sodium delayed-release tablets 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 prescribing information, Adverse R…

🔄 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 rabeprazole sodium delayed-release tablets 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 Rabeprazole sodium delayed-release tablets and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPI 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 rabeprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with rabeprazole may increase toxicity . • There are other antiretroviral drugs which do not result in clinically relevant interactions with rabeprazole.

Intervention: Rilpivirine-containing products : Concomitant use with rabeprazole sodium delayed-release tablets is contraindicated [see Contraindications (] . See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information.

Nelfinavir : Avoid concomitant use with rabeprazole sodium delayed-release tablets. 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 rabeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death [see Warnings and Precautions ()] .

Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.

Methotrexate Clinical Impact: Concomitant use of rabeprazole with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of methotrexate with PPIs have been conducted [see Warnings and Precautions ()]. Intervention: A temporary withdrawal of rabeprazole sodium delayed-release tablets may be considered in some patients receiving high dose methotrexate administration.

Digoxin Clinical Impact: Potential for increased exposure of digoxin [see Clinical Pharmacology ()]. Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.

See prescribing information for digoxin. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole) Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH.

The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving rabeprazole sodium delayed-release tablets and MMF. Use rabeprazole sodium delayed-release tablets with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.

Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use : Dosage strength not appropriate for patients less than 12 years ( 2 , ).

8.1Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

No evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times the human area under the plasma concentration-time curve (AUC) at the recommended dose for GERD, in rats and rabbits, respectively [see Data] . Changes in bone morphology were observed in offspring of rats treated with oral doses of a different PPI through most of pregnancy and lactation. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see Data].

Data Animal Data Embryo-fetal developmental studies have been performed in rats during organogenesis 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.

A pre-and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with a different PPI at about 3.4 to 57 times an oral human dose on a body surface area basis. Decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate, and minimal to mild bone marrow hypocellularity were noted at doses of this PPI equal to or greater than 3.4 times an oral human dose on a body surface area basis. Physeal dysplasia in the femur was also observed in offspring after in utero and lactational exposure to the PPI at doses equal to or greater than 33.6 times an oral human dose on a body surface area basis.

Effects on maternal bone were observed in pregnant and lactating rats in a pre-and postnatal toxicity study when the PPI was administered at oral doses of 3.4 to 57 times an oral human dose on a body surface area basis. When rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 33.6 times an oral human dose on a body surface area basis. A follow-up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with a different PPI at oral doses of 280 mg/kg/day (about 68 times an oral human dose on a body surface area basis) where drug administration was from either gestational day 7 or gestational day 16 until parturition.

When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age.

8.2Lactation Risk Summary Lactation studies have not been conducted to assess the presence of rabeprazole in human milk, the effects of rabeprazole on the breastfed infant, or the effects of rabeprazole on milk production. Rabeprazole is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for rabeprazole sodium delayed-release tablets…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

No evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times the human area under the plasma concentration-time curve (AUC) at the recommended dose for GERD, in rats and rabbits, respectively [see Data] . Changes in bone morphology were observed in offspring of rats treated with oral doses of a different PPI through most of pregnancy and lactation. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see Data].

Data Animal Data Embryo-fetal developmental studies have been performed in rats during organogenesis 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.

A pre-and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with a different PPI at about 3.4 to 57 times an oral human dose on a body surface area basis. Decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate, and minimal to mild bone marrow hypocellularity were noted at doses of this PPI equal to or greater than 3.4 times an oral human dose on a body surface area basis. Physeal dysplasia in the femur was also observed in offspring after in utero and lactational exposure to the PPI at doses equal to or greater than 33.6 times an oral human dose on a body surface area basis.

Effects on maternal bone were observed in pregnant and lactating rats in a pre-and postnatal toxicity study when the PPI was administered at oral doses of 3.4 to 57 times an oral human dose on a body surface area basis. When rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 33.6 times an oral human dose on a body surface area basis. A follow-up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with a different PPI at oral doses of 280 mg/kg/day (about 68 times an oral human dose on a body surface area basis) where drug administration was from either gestational day 7 or gestational day 16 until parturition.

When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of rabeprazole sodium delayed-release tablets have been established in pediatric patients for adolescent patients 12 years of age and older for the treatment of symptomatic GERD. Use of rabeprazole sodium delayed-release tablets in this age group is supported by adequate and well controlled studies in adults and a multicenter, randomized, open-label, parallel-group study in 111 adolescent patients 12 to 16 years of age. Patients had a clinical diagnosis of symptomatic GERD, or suspected or endoscopically proven GERD and were randomized to either 10 mg or 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy.

The adverse reaction profile in adolescent patients was similar to that of adults. The related reported adverse reactions that occurred in ≥2% of patients were headache (5%) and nausea (2%). There were no adverse reactions reported in these studies that were not previously observed in adults.

The safety and effectiveness of rabeprazole sodium delayed-release tablets have not been established in pediatric patients for: • Healing of Erosive or Ulcerative GERD • Maintenance of Healing of Erosive or Ulcerative GERD • Treatment of Symptomatic GERD • Healing of Duodenal Ulcers • Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence • Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Rabeprazole sodium delayed-release 20 mg tablets are not recommended for use in pediatric patients less than 12 years of age because the tablet strength exceeds the recommended dose for these patients [see Dosage and Administration ( 2 )].

For pediatric patients 1 year to less than 12 years of age consider another rabeprazole formulation. The safety and effectiveness of a different dosage form and dosage strength of rabeprazole has been established in pediatric patients 1 to 11 years for the treatment of GERD. Juvenile Animal Data 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 post-partum 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.

When juvenile animals were treated for 28 days with a different PPI at doses equal to or greater than 34 times the daily oral human dose on a body surface area basis, overall growth was affected and treatment-related decreases in body weight (approximately 14%) and body weight gain, and decreases in femur weight and femur length were observed.

🧓 Geriatric Use 74 words ▾

8.5Geriatric Use Of the total number of subjects (n=2,009) 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 94 words ▾

10 OVERDOSAGE 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 once daily. 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. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

🧬 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 on 24 hour gastric acidity is 88% of maximal after the first dose. A 20 mg dose of rabeprazole sodium delayed-release tablets 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 to 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 once daily) Placebo Basal Acid Output (mmol/hr) 0.4*

2.8Stimulated Acid Output (mmol/hr) 0.6* 13.3 % Time Gastric pH>3 65* 10 *(p<0.01 versus placebo) Compared to placebo, 10 mg, 20 mg, and 40 mg of rabeprazole sodium delayed-release tablets, 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) AUC interval (hrs) Rabeprazole sodium delayed-release tablets 10 mg (N=24) 20 mg (N=24) 40 mg (N=24) Placebo (N=24) 08:00 to 13:00 19.6±21.5 * 12.9±23* 7.6±14.7* 91.1±39.7 13:00 to 19:00 5.6±9.7* 8.3±29.8* 1.3±5.2* 95.5±48.7 19:00 to 22:00 0.1±0.1* 0.1±0.06* 0.0±0.02* 11.9±12.5 22:00 to 08:00 129.2±84* 109.6±67.2* 76.9±58.4* 479.9±165 AUC 0 to 24 hours 155.5±90.6* 130.9±81* 85.8±64.3* 678.5±216 *(p<0.001 versus placebo) After administration of 20 mg rabeprazole sodium delayed-release tablets once daily for eight days, the mean percent of time that gastric pH greater than 3 or gastric pH greater than 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 once daily Placebo Day 1 Day 8 Day 1 Day 8 Mean AUC 0-24 Acidity 340.8* 176.9* 925.5 862.4 Median trough pH (23-hr) a 3.77 3.51 1.27 1.38 % Time Gastric pH greater than 3 b 54.6* 68.7* 19.1 21.7 % Time Gastric pH greater than 4 b…

🧬 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 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rabeprazole Sodium Delayed-Release Tablets 20 mg is supplied as yellow, round , biconvex, beveled, coated tablets imprinted ‘20’ in black on one side. Bottles of 30 (NDC 68788-7459-03) Bottles of 60 (NDC 68788-7459-06) Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] . Protect from moisture.

📋 Description 189 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 figure is: 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 Mannitol, Crospovidone, Magnesium Oxide Light, Hydroxy Propyl Cellulose, Sodium Stearyl Fumarate, Magnesium Stearate, Ethyl Cellulose, Hypromellose phthalate, Carnauba Wax, Diacetylated Monoglyceride. The coating material contains Polyvinyl Alcohol, Talc, Titanium Dioxide, Macrogol, Lecithin and Iron Oxide Yellow.

The printing ink contains Shellac, Ferrosoferric Oxide, Propylene Glycol and Ammonium Hydroxide 28%. Rabe-Str

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with -acute tubulointerstitial nephritis [see Warnings and Precautions ()] . Clostridium difficile -Associated Diarrhea Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ()] .

Bone Fracture Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions ()] . Severe Cutaneous Adverse Reactions Advise the patient or caregiver to discontinue rabeprazole sodium delayed-release tablets and report any signs and symptoms of a severe cutaneous adverse reaction or other sign of hypersensitivity to the healthcare provider [see Warnings and Precautions ()] . Cutaneous and Systemic Lupus Erythematosus Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ()] .

Cyanocobalamin (Vitamin B-12) Deficiency Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving rabeprazole sodium delayed-release tablets for longer than 3 years [see Warnings and Precautions ()] . Hypomagnesemia and Mineral Metabolism Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, hypokalemia and hyponatremia to the patient’s healthcare provider, if they have been receiving rabeprazole sodium delayed-release tablets for at least 3 months [see Warnings and Precautions ()] .

Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications ( )], warfarin, digoxin or high-dose methotrexate [see Warnings and Precautions (, , )] . Administration • Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush or split the tablets. • For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal. • For Helicobacter pylori eradication take rabeprazole sodium delayed-release tablets with food. • For all other indications rabeprazole sodium delayed-release tablets can be taken with or without food. • Take a missed dose as soon as possible.

If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take two doses at the same time. Manufactured by: Alkem Laboratories Ltd., INDIA.

Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: August , 2023 All brand names are the trademarks of their respective owners. Dispense with Medication Guide available at: www.ascendlaboratories.com/mg/rabeprazoledrtabs.pdf PT 2191-07 Repackaged By: Preferred Pharmaceuticals Inc.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Rabeprazole Sodium (ra-BEP-ra-zole SOE-dee-um) Delayed-Release Tablets What is the most important information I should know about rabeprazole sodium delayed-release tablets? You should take rabeprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. 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: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including rabeprazole sodium delayed-release tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with rabeprazole sodium delayed-release tablets.

Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine).

Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body).

Some people who take PPI medicines, including rabeprazole sodium delayed-release tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.

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 tablet? Rabeprazole sodium delayed-release tablets is a prescription medicine called a proton pump inhibitor (PPI).

Rabeprazole sodium delayed-release tablets reduces the amount of acid in your stomach. In adults , Rabeprazole sodium delayed-release tablets is used for: • 8 weeks up to 16 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. • maintaining 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). • up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD). • up to 4 weeks for the healing and relief of symptoms of duodenal ulcers. • 7 days with certain antibiotic medicines to treat an infection and stomach (duodenal) ulcers caused by bacteria called H. pylori . • the long-term treatment of conditions where your stomach makes too much acid.

This includes a rare condition called Zollinger-Ellison syndrome. In adolescents 12 years of age and older , rabeprazole sodium delayed-release tablets is used for up to 8 weeks to treat symptoms of GERD. It is not known if rabeprazole sodium delayed-release tablets is safe and effective in children less than 12 years of age for other uses.

Rabeprazole sodium delayed-release tablets should not be used in children under 12 years of age. Do not take rabeprazole sodium delayed-release tablets if you are: • allergic to rabeprazole, any other PPI medicine, or any of the ingredients in rabeprazole sodium delayed-release tablets. See the end of this Medicat…

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