NDC 70000-0381-01 — Leader Omeprazole 20 mg

🆔 Identity & classification

FDA NDC (as labeled) 70000-0381-1

Product NDC 70000-0381

11-digit billing NDC 70000038101

NCPDP billing unit EA — each (per item)

RxCUI 2003656

UNII KG60484QX9

Application # NDA209400

SPL Set ID b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a

Established class (EPC) Proton Pump Inhibitor

Mechanism of action Proton Pump Inhibitors; Cytochrome P450 2C19 Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-08-20

Route ORAL

Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Substance OMEPRAZOLE

GPI-14 4927006000H320

GPI class Omeprazole

GCN Seq No 078481

GCN 44817

HICL code 004673

Ingredient (HICL) Omeprazole

HIC1 code D

Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System

HIC2 code D4

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract

HIC3 code D4J

Therapeutic class — specific (HIC3) Proton-Pump Inhibitors

AHFS code 56:28.36.00

AHFS class Proton-Pump Inhibitors

FDB label name OMEPRAZOLE DR 20 MG ODT

FDB brand name Omeprazole

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 70000-0381-1 — 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 → 70000-0381-01. 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

LabelerCardinal Health 110, LLC. dba Leader

Application holderDEXCEL PHARMA TECHNOLOGIES LTD

FDA applicationNDA209400 (NDA)

Labeler code70000

First marketedAug 2018

Product typeHuman Otc Drug

Portfolio163 products on file

🔎 All NDCs from Cardinal Health 110, LLC. dba Leader

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OMEPRAZOLE DR 20 MG ODT Ingredient Omeprazole

📖 What it is MedlinePlus · NLM

Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with G...

Read the full MedlinePlus article ↗

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Omeprazole — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Omeprazole (174 interactions) — ranked by severity →

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.

CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Major Depletion ZINC Insignificant Depletion +4 more

🧪 Full Omeprazole 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 Red

ShapeRound

Imprint20

Size9 mm

ScoringNot scored

FlavorStrawberry

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.444	$6.21 / 14 tablet
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per ea) — tap or hover for the price & month

Flat over the last 24 months.

Where does this data come from?

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

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
good sense omeprazole 20 mg 00113-0520-55	L.	1 tablet	$0.444	—	Availability likely	—
good neighbor pharmacy omeprazole 20 mg 46122-0616-04	Amerisource	1 tablet	$0.444	—	Availability likely	—
Leader Omeprazole 20 mgthis 70000-0381-01	Cardinal	1 tablet	$0.444	—	Availability likely	—
omeprazole 20 mg 00363-1819-55	Walgreen	1 tablet	—	—	FDA listed	—
up and up omeprazole 20 mg 11673-0212-55	Target	1 tablet	—	—	FDA listed	—
omeprazole 20 mg 11822-1040-01	Rite	1 tablet	—	—	Discontinued	—
Signature Care Omeprazole 20 mg 21130-0128-55	Safeway	1 tablet	—	—	FDA listed	—
omeprazole 20 mg 30142-0394-55	Kroger	1 tablet	—	—	FDA listed	—
topcare omeprazole 20 mg 36800-0601-55	Topco	1 tablet	—	—	FDA listed	—
omeprazole 20 mg 37808-0354-55	H	1 tablet	—	—	FDA listed	—
equaline omeprazole 20 mg 41163-0634-74	United	1 tablet	—	—	FDA listed	—
Omeprazole 20 mg 41250-0349-55	Meijer	1 tablet	—	—	FDA listed	—
careone omeprazole 20 mg 41520-0939-55	American	1 tablet	—	—	FDA listed	—
omeprazole 20 mg 42507-0164-42	HyVee	1 tablet	—	—	FDA listed	—
DG health omperazole 20 mg 55910-0713-30	Dolgencorp	1 tablet	—	—	FDA listed	—
berkley and jensen omeprazole 20 mg 68391-0103-55	BJWC	1 tablet	—	—	FDA listed	—
Omeprazole 20 mg 69842-0791-55	CVS	1 tablet	—	—	FDA listed	—
Basic Care Omeprazole 20 mg 72288-0123-55	Amazon.com	1 tablet	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2017

First FDA approval

Jul 2017

📍

2026

Currently FDA-listed

9 years listed

🛡️

2036

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 5, 2017 RLD RS ⏳ ~10.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 10835488 — drug product

US 10076494 — drug product

2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)

Patent	Type	Use code	Expires
US 10835488 ↗	Drug product	—	Dec 8, 2036
US 10076494 ↗	Drug product	—	Dec 8, 2036

Common questions

Is there a generic version of OMEPRAZOLE DR 20 MG ODT?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for OMEPRAZOLE DR 20 MG ODT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2036 — an estimate, not a guaranteed launch date.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tablet70000-0381-02 604 Rx · $12,069

1 tablet this page70000-0381-01 No Medicaid data

Drug total (last 4 qtrs): 604 Rx · 26,422 units · $12,069 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Omeprazole (matched by generic name) — 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
70000-0381-01 You're viewing this	14 BLISTER PACK in 1 CARTON (70000-0381-1) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	$0.4435 / ea	$6.21	2018-08-20	Active
70000-0381-02	3 CARTON in 1 CARTON (70000-0381-2) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	$0.4435 / ea	$18.63	2018-08-20	Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.4435 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70000-0381-01?

NDC 70000-0381-01 is listed by the FDA — 14 blister pack in 1 carton / 1 tablet, orally disintegrating, delayed release in 1 blister pack.

What NDC number is used to bill for this package of Leader Omeprazole 20 mg Tablet, Orally Disintegrating, Delayed Release?

Bill NDC 70000-0381-01 — the 11-digit billing format is 70000038101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 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 188 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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • do not take this medicine with alcohol Repeated 14-Day Course (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 before use.

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

⚠️ Warnings 12 words ▾

Warnings Allergy alert: do not use if you are allergic to omeprazole

📦 Storage and Handling 31 words ▾

Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F); keep product out of high heat and moisture

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Omeprazole 20 mg

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, 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 ↗

🔗 Related NDC lookups

🧪 All Omeprazole NDCsSame ingredient 🏭 All Cardinal labeler NDCsLabeler code 70000 📚 All Proton Pump Inhibitor NDCsDrug class 📖 Read the Omeprazole drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Proton-Pump Inhibitors.

Lansoprazole 00093-3008-93 Omeprazole Magnesium 00363-0042-01 Rabeprazole Sodium 67877-0443-30

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.