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Acid Reducer Omeprazole 20 mg Tablet, Delayed Release — NDC 53943-0016-62 package photo

Acid Reducer Omeprazole 20 mg Tablet, Delayed Release

by DISCOUNT DRUG MART · 3 BOTTLE in 1 CARTON (53943-016-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
NDC 53943-0016-62
🏷️ FDA NDC (as labeled) 53943-016-62 billing pads the product segment with a zero
This package
Contains14 tablet, delayed release in 1 bottle Pack sizes2 compare ↓
Also comes in: 14 tablets 53943-0016-05
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 →

This page is curated, coded, and maintained by

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

⚠️
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) 53943-016-62
Product NDC 53943-016
11-digit billing NDC 53943001662
RxCUI 402014
UNII 426QFE7XLK
UPC 0093351028601
Application # ANDA206877
SPL Set ID ff2c8446-9d8b-4300-b157-884b48e98bb7
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 2018-06-06
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM
Why two NDCs? The FDA registers this code as 53943-016-62 — 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 → 53943-0016-62. 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

LabelerDISCOUNT DRUG MART
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA206877 (ANDA)
Labeler code53943
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio130 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

📖 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 →
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.

🧪 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 Pink
ShapeRectangle
ImprintZ;69
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.

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 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 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
Acid Reducer 20 mg 70000-0521-01 Cardinal 14 tablets $0.383 — FDA listed —
rugby omeprazole 20 mg 00536-1448-13 Rugby 14 tablets $0.390 — Availability likely —
omeprazole 20 mg 45802-0888-30 Padagis 1 tablet $0.390 — Availability likely —
good neighbor pharmacy omeprazole 20 mg 46122-0029-03 Amerisource 1 tablet $0.390 — Availability likely —
good neighbor pharmacy omeprazole 20 mg 46122-0281-04 Amerisource 14 tablets $0.390 — Availability likely —
Omeprazole 20 mg 46122-0739-03 AMERISOURCEBERGEN 14 tablets $0.390 — Discontinued —
Omeprazole 20 mg 51660-0029-14 OHM 14 tablets $0.390 — Availability likely —
Omeprazole 20 mg 68001-0441-39 BluePoint 14 tablets $0.390 — Availability likely —
leader omeprazole 20 mg 70000-0723-01 Cardinal 14 tablets $0.390 — Availability likely —
Omeprazole 20 mg 70677-1098-01 STRATEGIC 14 tablets $0.390 — Availability likely —
foster and thrive omeprazole 20 mg 70677-1104-01 Strategic 1 tablet $0.390 — Availability likely —
foster and thrive omeprazole 20 mg 70677-1275-01 Strategic 14 tablets $0.390 — Availability likely —
Omeprazole 20 mg 70677-0148-01 Strategic 14 tablets $0.424 — FDA listed —
Acid Reducer 20 mg 00536-1322-13 Rugby 14 tablets $0.459 — Availability likely —
Omeprazole 20 mg 83324-0011-14 CHAIN 14 tablets $0.459 — Availability likely —
Good Sense Omeprazole 20 mg 00113-0915-03 L. 14 tablets — — FDA listed —
Good Sense Omeprazole 20 mg 00113-1723-01 L. 14 tablets — — FDA listed —
good sense omeprazole delayed release 20 mg 00113-1803-03 L. 14 tablets — — FDA listed —
omeprazole 20 mg 00363-0007-01 Walgreen 14 tablets — — FDA listed —
omeprazole 20 mg 00363-0915-01 Walgreen 14 tablets — — FDA listed —
Acid Reducer 20 mg 00363-1008-05 WALGREEN 14 tablets — — FDA listed —
Omeprazole 20 mg 00363-1607-14 Walgreens 14 tablets — — FDA listed —
omeprazole 20 mg 00363-6101-03 Walgreen 14 tablets — — FDA listed —
Omeprazole 20.6 mg 00363-9510-14 Walgreens 14 tablets — — FDA listed —
Acid Reducer 20 mg 10202-0722-05 7-Eleven 14 tablets — — FDA listed —
up and up omeprazole 20 mg 11673-0018-01 Target 14 tablets — — FDA listed —
up and up omeprazole 20 mg 11673-0346-03 Target 14 tablets — — FDA listed —
up and up omeprazole 20 mg 11673-0915-01 Target 14 tablets — — FDA listed —
omeprazole 20 mg 11822-0453-01 Rite 14 tablets — — Discontinued —
omeprazole 20 mg 11822-0915-04 Rite 14 tablets — — Discontinued —
omeprazole 20 mg 11822-1190-01 Rite 14 tablets — — FDA listed —
Omeprazole 20 mg 21130-0018-14 Albertsons 14 tablets — — Discontinued —
Signature Care Omeprazole 20 mg 21130-0137-30 Safeway 1 tablet — — Discontinued —
signature care omeprazole 20 mg 21130-0401-01 Safeway 14 tablets — — FDA listed —
Omeprazole 20 mg 21130-0991-28 Living 14 tablets — — FDA listed —
Omeprazole 20 mg 25000-0091-76 MARKSANS 14 tablets — — FDA listed —
Acid Reducer 20 mg 30142-0077-01 KROGER 14 tablets — — FDA listed —
omeprazole 20 mg 30142-0474-01 Kroger 14 tablets — — FDA listed —
omeprazole 20 mg 30142-0557-01 Kroger 14 tablets — — FDA listed —
Omeprazole 20 mg 30142-0593-01 Kroger 14 tablets — — FDA listed —
omeprazole 20 mg 30142-0992-14 THE 14 tablets — — FDA listed —
TopCare Omeprazole delayed release 20 mg 36800-0121-01 Topco 14 tablets — — FDA listed —
TopCare Omeprazole 20 mg 36800-0915-01 Topco 14 tablets — — FDA listed —
Prilosec OTC 20.6 mg 37000-0455-01 The 1 tablet — — FDA listed —
Prilosec OTC 20 mg 37000-0459-01 The 1 tablet — — FDA listed —
omeprazole 20 mg 37808-0401-01 H 14 tablets — — FDA listed —
omeprazole 20 mg 37808-0915-01 H 14 tablets — — FDA listed —
Omeprazole 20 mg 37835-0001-42 BI-MART 14 tablets — — FDA listed —
Acid Reducer 20 mg 37835-0189-14 Bi-Mart 14 tablets — — FDA listed —
equaline omeprazole 20 mg 41163-0915-01 United 14 tablets — — FDA listed —
omeprazole 20 mg 41250-0401-01 Meijer 14 tablets — — FDA listed —
omeprazole 20 mg 41250-0915-01 Meijer 14 tablets — — FDA listed —
careone omeprazole 20 mg 41520-0802-03 American 14 tablets — — FDA listed —
care one omeprazole 20 mg 41520-0915-03 American 14 tablets — — FDA listed —
omeprazole 20 mg 42507-0414-01 HyVee 14 tablets — — FDA listed —
omeprazole 20 mg 42507-0915-01 HyVee 14 tablets — — FDA listed —
Omeprazole 20 mg 43598-0286-25 Dr. 14 tablets — — FDA listed —
Omeprazole 20 mg 43598-0841-42 Dr. 14 tablets — — FDA listed —
equate omeprazole 20 mg 49035-0119-01 Wal-Mart 14 tablets — — FDA listed —
Equate omeprazole delayed release acid reducer 20 mg 49035-0915-01 Wal-Mart 14 tablets — — FDA listed —
Acid Reducer 20 mg 49035-0983-62 Wal-Mart 14 tablets — — FDA listed —
Omeprazole delayed release 20 mg 49483-0731-41 TIME 14 tablets — — FDA listed —
Omeprazole 20 mg 50090-6888-00 A-S 14 tablets — — FDA listed —
Acid Reducer 20 mgthis 53943-0016-62 DISCOUNT 14 tablets — — FDA listed —
exchange select omeprazole 20 mg 55301-0915-55 Army 1 tablet — — FDA listed —
Acid Reducer 20 mg 55315-0996-04 Fred's, 14 tablets — — FDA listed —
Acid Reducer 20 mg 55319-0037-05 Family 14 tablets — — FDA listed —
Omeprazole 20.6 mg 55319-0219-14 Family 14 tablets — — FDA listed —
Omeprazole 20 mg 55681-0306-14 Twin 14 tablets — — FDA listed —
dg health omeprazole 20 mg 55910-0215-01 Dolgencorp 14 tablets — — FDA listed —
dg health omeprazole 20 mg 55910-0712-01 Dolgencorp 14 tablets — — FDA listed —
dg health omeprazole 20 mg 55910-0915-02 Dolgencorp, 14 tablets — — FDA listed —
omeprazole 20 mg 56062-0401-01 Publix 14 tablets — — FDA listed —
omeprazole 20 mg 56062-0915-30 Publix 1 tablet — — FDA listed —
Acid Reducer 20 mg 57483-0120-42 INNOVUS 14 tablets — — FDA listed —
omeprazole 20 mg 57483-0840-42 INNOVUS 14 tablets — — FDA listed —
Omeprazole 20 mg 57896-0659-42 GERI-CARE 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0729-01 Aurohealth 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0826-05 Aurohealth 14 tablets — — FDA listed —
Acid Reducer 20 mg 58602-0850-05 Aurohealth 14 tablets — — FDA listed —
omeprazole 20 mg 59640-0047-03 H 14 tablets — — FDA listed —
Omeprazole 20.6 mg 59726-0298-14 P 14 tablets — — FDA listed —
Omeprazole 20 mg 59726-0740-42 P 14 tablets — — FDA listed —
Omeprazole 20 mg 59726-0744-42 P 14 tablets — — FDA listed —
omeprazole 20 mg 59779-0503-01 CVS 14 tablets — — FDA listed —
Omeprazole 20 mg 59779-0580-01 CVS 14 tablets — — FDA listed —
Omeprazole 20 mg 62756-0377-11 Sun 14 tablets — — FDA listed —
Omeprazole 20.6 mg 63548-2970-02 PLD 42 tablets — — FDA listed —
Omeprazole 20.6 mg 63548-4080-02 PLD 1 tablet — — FDA listed —
Omeprazole 20.6 mg 63548-7370-02 PLD 42 tablets — — FDA listed —
Omeprazole 20.6 mg 63548-8040-02 PLD 1 tablet — — FDA listed —
Omeprazole 20 mg 63868-0471-14 Chain 14 tablets — — Discontinued —
Acid Reducer 20 mg 63941-0006-05 Best 14 tablets — — FDA listed —
Omeprazole 20 mg 63941-0997-14 VALU 14 tablets — — FDA listed —
kirkland signature omeprazole 20 mg 63981-0915-55 Costco 1 tablet — — FDA listed —
Omeprazole, 24/7 Life by 7-Eleven 20.6 mg 66715-6550-04 Lil' 14 tablets — — FDA listed —
Acid Reducer 20 mg 67091-0316-14 Winco 14 tablets — — FDA listed —
Omeprazole 20.6 mg 67091-0464-14 WinCo 14 tablets — — FDA listed —
Omeprazole 20 mg 67296-2183-08 Redpharm 14 tablets — — FDA listed —
members mark omeprazole 20 mg 68196-0700-01 Sam's 14 tablets — — FDA listed —
members mark omeprazole 20 mg 68196-0915-01 Sam's 14 tablets — — Discontinued —
Berkley and Jensen Omeprazole 20 mg 68391-0915-55 BJWC 1 tablet — — FDA listed —
Omeprazole 20 mg 69168-0476-14 Allegiant 14 tablets — — FDA listed —
Omeprazole 20 mg 69230-0318-05 Camber 500 tablets — — FDA listed —
Acid Reducer 20 mg 69618-0054-42 RELIABLE 14 tablets — — FDA listed —
Omeprazole 20 mg 69842-0661-01 CVS 14 tablets — — FDA listed —
Omeprazole 20 mg 72036-0981-14 HARRIS 14 tablets — — FDA listed —
basic care omeprazole 20 mg 72288-0047-01 Amazon.com 14 tablets — — FDA listed —
basic care omeprazole 20 mg 72288-0401-01 Amazon.com 14 tablets — — FDA listed —
Amazon Basic Care Omeprazole 20 mg 72288-0409-01 Amazon.com 14 tablets — — FDA listed —
basic care omeprazole 20 mg 72288-0915-01 Amazon.com 14 tablets — — FDA listed —
careone omeprazole 20 mg 72476-0473-01 Retail 14 tablets — — FDA listed —
omeprazole 20 mg 72559-0014-06 Little 14 tablets — — FDA listed —
topcare omeprazole 20 mg 76162-0470-01 Topco 14 tablets — — FDA listed —
24 hr omeprazole 20 mg 79481-0075-01 Meijer, 14 tablets — — FDA listed —
equate omeprazole 20 mg 79903-0113-14 WALMART 14 tablets — — FDA listed —
Omeprazole 20 mg 79903-0305-28 Walmart 14 tablets — — FDA listed —
Omeprazole 20.6 mg 79903-0377-14 WALMART 14 tablets — — FDA listed —
Acid Reducer 20 mg 80136-0852-03 NORTHEAST 14 tablets — — FDA listed —
good now omeprazole 20 mg 82501-0915-00 Gobrands, 1 tablet — — FDA listed —
Omeprazole 20 mg 83324-0141-14 Chain 14 tablets — — FDA listed —
Prilosec OTC 20.6 mg 84126-0300-14 The 14 tablets — — FDA listed —
Prilosec OTC 20.6 mg 84126-0301-14 The 14 tablets — — FDA listed —
24 HOUR Omeprazole 20 mg 85828-0731-45 Grocery 14 tablets — — FDA listed —
Acid Reducer 20 mg 69842-0941-01 CVS 14 tablets — — FDA listed —
Omeprazole Delayed-Release 20 mg 37808-0569-41 H-E-B 14 tablets — — 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
Jun 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 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.

🔬 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 Acid Reducer (this brand).

Top reported reactions

Nausea26,681
Fatigue26,379
Diarrhoea25,937
Dyspnoea21,608
Headache20,104
Pain18,935
Vomiting17,609

Reporter sex

474,713 reports
Male · 41%
Female · 59%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 63,169 14,561
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
53943-0016-05 1 BOTTLE in 1 CARTON (53943-016-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2018-06-06 Active
53943-0016-62 You're viewing this 3 BOTTLE in 1 CARTON (53943-016-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2018-06-06 Active

Pack size FAQ

What quantity is in NDC 53943-0016-62?
NDC 53943-0016-62 is listed by the FDA — 3 bottle in 1 carton / 14 tablet, delayed release in 1 bottle.
What NDC number is used to bill for this package of Acid Reducer Omeprazole 20 mg Tablet, Delayed Release?
Bill NDC 53943-0016-62 — the 11-digit billing format is 53943001662. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 53943-016-62, 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: 53943-0016-62, written without dashes as 53943001662. 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 53943-0016-62, the first segment (53943) is the labeler code FDA assigned to DISCOUNT DRUG MART; the middle segment (0016) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (62) 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 DISCOUNT DRUG MART. 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 tablets (53943-0016-05). 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?
DISCOUNT DRUG MART 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 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 153 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 tablet with a glass of water before eating in the morning 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 swallow whole. Do not chew or crush tablets. 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 12 words ▾

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

📦 Storage and Handling 28 words ▾

Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º to 25ºC(68º to 77º F) and protect from moisture

🧪 Active Ingredient 17 words ▾

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

🧪 Inactive Ingredients 50 words ▾

Inactive ingredients crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.

🎯 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 ↗
← 53943-0009-09 · Discount 53943-0022-32 · Discount →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.