HomeNDC LookupIngredientsOmeprazole › 21130-0783-03
OMEPRAZOLE 20 mg Capsule, Delayed Release — NDC 21130-0783-03 package photo

OMEPRAZOLE 20 mg Capsule, Delayed Release

by Safeway · 3 BOTTLE in 1 CARTON (21130-783-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
NDC 21130-0783-03
🏷️ FDA NDC (as labeled) 21130-783-03 billing pads the product segment with a zero
This package
Contains14 capsule, delayed release in 1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $0.2027/unit — full pricing hub ↓
Also comes in: 14 capsules 21130-0783-01
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Omeprazole (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 30, 2025 — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0525-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 21130-783-03
Product NDC 21130-783
11-digit billing NDC 21130078303
RxCUI 198051
UNII 426QFE7XLK
Application # ANDA216096
SPL Set ID b3ec4a44-5643-4438-b41b-e04946436719
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-27
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM
Why two NDCs? The FDA registers this code as 21130-783-03 — 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 → 21130-0783-03. 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, Cytochrome P450 2C19 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

LabelerSafeway
Application holderDEXCEL PHARMA TECHNOLOGIES LTD
FDA applicationANDA216096 (ANDA)
Labeler code21130
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio158 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
  • Omeprazole turns down your stomach's acid production by blocking the pump that makes acid in the first place. Depending on why you're taking it, that can mean relief from heartburn...
  • What exactly is omeprazole supposed to do for me?
  • Take it about 30 minutes before a meal, ideally before breakfast. Taking it before eating gives it the best chance to be absorbed and ready to work when your stomach starts produci...
  • When should I take it — before or after eating?
📖 Read our full Omeprazole guide →
9
Nutrient depletion considerations

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

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

💊 What it looks like

Color White / Orange
ShapeCapsule
Imprint57S
Size14 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 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 6HG8UB2MUY
    Meglumine is a sugar-alcohol compound used as a solubilizer and pH buffer in medicines. It helps dissolve drugs that don't mix well in water and maintains stable acidity levels in the formulation.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesFD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 $0.2027 $8.51 / 42 capsules
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
Omeprazole 20 mg 00904-6917-61 Major 1 capsule $0.028 AB Availability likely
Omeprazole 20 mg 16714-0634-01 NorthStar 30 capsules $0.028 AB Availability likely
Omeprazole 20 mg 16714-0715-01 NorthStar 30 capsules $0.028 AB Discontinued
Omeprazole 20 mg 55111-0158-01 Dr. 100 capsules $0.028 Availability likely
Omeprazole 20 mg 55111-0644-01 Dr. 100 capsules $0.028 AB Availability likely
Omeprazole 20 mg 60505-0065-00 Apotex 30 capsules $0.028 AB Discontinued
Omeprazole 20 mg 60687-0597-01 American 1 capsule $0.028 AB Availability likely
Omeprazole 20 mg 68084-0128-01 American 1 capsule $0.028 AB Discontinued
Omeprazole 20 mg 68382-0412-01 Zydus 100 capsules $0.028 AB Availability likely
Omeprazole 20 mg 68462-0396-01 Glenmark 100 capsules $0.028 AB Availability likely
Omeprazole 20 mg 82009-0022-10 Quallent 1000 capsules $0.028 AB Availability likely
Omeprazole 20 mg 82009-0183-10 Quallent 1000 capsules $0.028 AB Availability likely
Omeprazole 20 mg 00781-2868-01 Sandoz 100 capsules $0.029 AB Availability likely
Omeprazole 20 mg 60505-3952-03 Apotex 30 capsules $0.034 AB Discontinued
Omeprazole 20 mg 62175-0118-32 Lannett 30 capsules $0.036 AB FDA listed
Omeprazole 20.6 mg 46122-0686-03 AMERISOURCE 14 capsules $0.408 Discontinued
Omeprazole Magnesium 20 mg 55111-0397-27 Dr. 14 capsules $0.408 Availability likely
Acid Reducer 20 mg 70000-0232-01 LEADER/ 14 capsules $0.408 Availability likely
Omeprazole Magnesium 20 mg 83324-0117-14 Chain 14 capsules $0.408 Availability likely
Omeprazole Magnesium 20 mg 00363-0042-01 Walgreens 14 capsules FDA listed
Omeprazole 20 mg 00363-4099-03 Walgreen 14 capsules FDA listed
omeprazole 20 mg 00363-6089-01 Walgreen 14 capsules FDA listed
Omeprazole 20 mg 00363-9980-14 Walgreen 14 capsules FDA listed
Omeprazole 20 mg 00615-8406-05 NCS 15 capsules AB FDA listed
Omeprazole 20 mg 00781-2790-01 Sandoz 100 capsules AB FDA listed
Omeprazole 20 mg 11673-0948-14 UP 14 capsules FDA listed
omeprazole 20.6 mg 11822-0061-04 Rite 14 capsules FDA listed
Omeprazole Magnesium 20 mg 21130-0398-33 Albertsons 14 capsules FDA listed
omeprazole 20 mg 21130-0528-01 Safeway 14 capsules FDA listed
Omeprazole 20 mgthis 21130-0783-03 Safeway 14 capsules FDA listed
Omeprazole Magnesium 20 mg 30142-0012-01 The 14 capsules FDA listed
omeprazole 20 mg 31722-0528-01 Camber 100 capsules AB FDA listed
Omeprazole Magnesium 20 mg 37808-0006-33 HEB 14 capsules FDA listed
Omeprazole 20 mg 42708-0170-14 QPharma 14 capsules AB FDA listed
Omeprazole 20 mg 42708-0199-14 QPharma 14 capsules AB FDA listed
Omeprazole 20 mg 43063-0743-14 PD-Rx 14 capsules AB FDA listed
Omeprazole Magnesium 20 mg 43598-0813-14 Dr. 14 capsules FDA listed
Omeprazole Magnesium 20 mg 49035-0397-27 Wal-Mart 14 capsules FDA listed
Omeprazole 20 mg 49999-0265-14 Quality 14 capsules AB Discontinued
Omeprazole 20 mg 50090-1157-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-3876-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-5111-00 A-S 90 capsules AB FDA listed
Omeprazole 20 mg 50090-5901-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-5902-00 A-S 90 capsules AB FDA listed
Omeprazole 20 mg 50090-7018-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-7019-00 A-S 90 capsules AB FDA listed
Omeprazole 20 mg 50090-7021-00 A-S 1 capsule AB FDA listed
Omeprazole 20 mg 50090-7213-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-7214-00 A-S 100 capsules AB FDA listed
Omeprazole 20 mg 50090-7215-00 A-S 90 capsules AB FDA listed
Omeprazole 20 mg 50090-7472-00 A-S 30 capsules AB FDA listed
Omeprazole 20 mg 50090-7473-00 A-S 100 capsules AB FDA listed
Omeprazole 20 mg 50090-7474-00 A-S 90 capsules AB FDA listed
Omeprazole 20 mg 51316-0061-28 CVS 28 capsules FDA listed
omeprazole 20 mg 51316-0271-03 CVS 14 capsules FDA listed
Omeprazole 20 mg 51316-0843-03 CVS 14 capsules FDA listed
Omeprazole 20 mg 51407-0287-01 Golden 100 capsules AB Discontinued
Omeprazole 20 mg 51407-0641-00 Golden 1 capsule AB FDA listed
Omeprazole 20 mg 51407-0813-01 Golden 100 capsules AB FDA listed
Omeprazole 20 mg 51655-0061-25 Northwind 60 capsules AB FDA listed
Omeprazole 20 mg 51655-0893-25 Northwind 60 capsules AB FDA listed
Omeprazole Magnesium 20 mg 53943-0520-14 Discount 14 capsules FDA listed
Omeprazole 20 mg 55154-2332-00 Cardinal 1 capsule AB FDA listed
Omeprazole 20 mg 57237-0161-01 Rising 100 capsules AB FDA listed
omeprazole 20.6 mg 57483-0740-42 INNOVUS 14 capsules FDA listed
Omeprazole Magnesium 20.6 mg 57896-0759-14 Gericare 14 capsules FDA listed
Omeprazole 20 mg 58602-0837-05 Aurohealth 14 capsules FDA listed
Omeprazole 20 mg 59651-0002-01 Aurobindo 100 capsules FDA listed
Omeprazole 20 mg 60760-0747-07 St. 7 capsules AB FDA listed
Omeprazole 20 mg 60760-0833-30 St. 30 capsules AB FDA listed
Omeprazole 20 mg 60760-0868-07 St. 7 capsules AB FDA listed
Omeprazole 20 mg 63187-0070-14 Proficient 14 capsules AB FDA listed
Omeprazole 20 mg 63187-0820-06 Proficient 6 capsules AB FDA listed
Omeprazole Magnesium 20 mg 63868-0177-15 Chain 14 capsules FDA listed
Omeprazole 20 mg 65841-0760-01 Zydus 100 capsules AB FDA listed
Omeprazole 20 mg 67046-1509-03 Coupler 30 capsules AB FDA listed
Omeprazole 20 mg 67296-1939-03 Redpharm 30 capsules AB FDA listed
Omeprazole Magnesium 20 mg 68016-0760-14 Chain 14 capsules FDA listed
Omeprazole 20 mg 68071-2243-07 NuCare 7 capsules AB FDA listed
Omeprazole 20 mg 68071-2262-03 NuCare 30 capsules AB FDA listed
Omeprazole 20 mg 68071-3007-02 NuCare 28 capsules AB FDA listed
Omeprazole 20 mg 68071-3733-02 NuCare 20 capsules AB FDA listed
Omeprazole 20 mg 68071-4024-03 NuCare 30 capsules AB FDA listed
Omeprazole 20 mg 68071-4025-03 NuCare 30 capsules AB FDA listed
Omeprazole 20 mg 68788-4104-01 Preferred 100 capsules AB FDA listed
Omeprazole 20 mg 68788-6881-01 Preferred 100 capsules AB FDA listed
Omeprazole 20 mg 68788-8805-01 Preferred 100 capsules AB FDA listed
Omeprazole 20 mg 68788-8864-01 Preferred 100 capsules AB FDA listed
Omeprazole Magnesium 20 mg 69842-0027-01 CVS 14 capsules FDA listed
Omeprazole 20 mg 70518-2251-00 REMEDYREPACK 30 capsules AB Discontinued
Omeprazole 20 mg 70518-3278-00 REMEDYREPACK 30 capsules AB Discontinued
Omeprazole 20 mg 70518-4177-00 REMEDYREPACK 30 capsules AB FDA listed
Omeprazole 20 mg 70700-0150-00 Xiromed, 1 capsule AB FDA listed
Omeprazole 20 mg 71205-0613-14 Proficient 14 capsules AB FDA listed
Omeprazole 20 mg 71205-0907-00 Proficient 100 capsules AB FDA listed
Omeprazole 20 mg 71335-0332-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71335-0569-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71335-1636-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71335-1746-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71335-1852-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71335-9609-00 Bryant 7 capsules AB FDA listed
Omeprazole 20 mg 71610-0663-30 Aphena 30 capsules AB FDA listed
Omeprazole 20 mg 71610-0912-30 Aphena 30 capsules AB FDA listed
Omeprazole 20 mg 71610-0942-30 Aphena 30 capsules AB FDA listed
Omeprazole 20 mg 71610-0963-60 Aphena 90 capsules AB FDA listed
basic care omeprazole 20 mg 72288-0023-03 Amazon.com 42 capsules FDA listed
omeprazole 20 mg 72288-0606-03 Amazon.com 14 capsules FDA listed
Omeprazole 20 mg 72789-0482-14 PD-Rx 14 capsules AB FDA listed
Omeprazole 20 mg 76420-0055-03 Asclemed 30 capsules AB FDA listed
Omeprazole 20.6 mg 79481-0061-03 Meijer 42 capsules FDA listed
omeprazole 20 mg 79481-0281-00 Meijer, 14 capsules FDA listed
omeprazole 20 mg 79481-3023-01 Meijer, 14 capsules FDA listed
equate omeprazole 20 mg 79903-0112-14 WALMART 14 capsules FDA listed
Omeprazole DR 20 mg 80425-0070-01 Advanced 30 capsules AB FDA listed
Omeprazole DR 20 mg 80425-0071-01 Advanced 30 capsules AB FDA listed
Omeprazole 20 mg 80425-0415-01 Advanced 30 capsules AB FDA listed
Omeprazole 20 mg 80425-0504-01 Advanced 30 capsules AB FDA listed
Omeprazole 20 mg 82868-0043-60 Northwind 60 capsules AB FDA listed
Omeprazole 20 mg 83209-0150-05 Boswell 5 capsules AB FDA listed
Omeprazole 20 mg 85509-1396-01 PHOENIX 120 capsules AB FDA listed
Omeprazole 20 mg 85509-1644-01 PHOENIX 120 capsules AB FDA listed
Good Sense Omeprazole 20 mg 00113-6010-03 L. 14 capsules FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

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

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

Medicare Part D (outpatient prescription) spending for Omeprazole — the program that covers self-administered drugs. 14 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 Omeprazole. 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
$75.01M
Claims incl. refills
7.1M
Beneficiaries
5.3M
Spend / beneficiary
$14.18
Spend / claim
$10.59
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Omeprazole — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease36,807
Nausea27,095
Fatigue26,259
Diarrhoea25,668
Acute Kidney Injury23,964
Dyspnoea21,145
Pain20,498

Age at onset

Neonate292
Infant271
Child706
Adolescent877
Adult32,838
Elderly30,558

Reporter sex

448,293 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization150,621
Death39,276
Life-threatening19,121
Disabling14,768
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 45,465 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
21130-0783-01 1 BOTTLE in 1 CARTON (21130-783-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2026-05-18 Active
21130-0783-03 You're viewing this 3 BOTTLE in 1 CARTON (21130-783-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2026-04-27 Active

Pack size FAQ

What quantity is in NDC 21130-0783-03?
NDC 21130-0783-03 is listed by the FDA — 3 bottle in 1 carton / 14 capsule, delayed release in 1 bottle.
What NDC number is used to bill for this package of OMEPRAZOLE 20 mg Capsule, Delayed Release?
Bill NDC 21130-0783-03 — the 11-digit billing format is 21130078303. 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

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — 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 21130-783-03, 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: 21130-0783-03, written without dashes as 21130078303. 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 21130-0783-03, the first segment (21130) is the labeler code FDA assigned to Safeway; the middle segment (0783) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Safeway. 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 14 capsules (21130-0783-01). 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?
Safeway 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 31 words

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

⏱️ Dosage and Administration 164 words

Directions • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush capsules. Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor.

Heartburn in children may sometimes be caused by a serious condition.

⚠️ Warnings ~1 min read

Warnings Allergy alert: • do not use if you are allergic to omeprazole. • Omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition.

See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug.

Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 16 words

Active ingredient (in each capsule) Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium)

🧪 Inactive Ingredients 33 words

Inactive ingredients FD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

🎯 Purpose 3 words

Purpose Acid reducer

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