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dg health omeprazole 20 mg Tablet, Delayed Release — NDC 55910-0915-03 package photo

dg health omeprazole 20 mg Tablet, Delayed Release

by Dolgencorp, LLC · 3 BOTTLE in 1 CARTON (55910-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
NDC 55910-0915-03
🏷️ FDA NDC (as labeled) 55910-915-03 billing pads the product segment with a zero
This package
Contains14 tablet, delayed release in 1 bottle Pack sizes4 compare ↓
Also comes in: 1 tablet 55910-0915-30 1 tablet 55910-0915-74 14 tablets 55910-0915-02
OTC Brand 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) 55910-915-03
Product NDC 55910-915
11-digit billing NDC 55910091503
RxCUI 402014
UNII KG60484QX9
Application # NDA022032
SPL Set ID 326bf21c-fad4-473e-9e7f-797319d4353a
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 2010-02-14
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance OMEPRAZOLE
Why two NDCs? The FDA registers this code as 55910-915-03 — 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 → 55910-0915-03. 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

LabelerDolgencorp, LLC
Application holderDEXCEL PHARMA TECHNOLOGIES LTD
FDA applicationNDA022032 (NDA)
Labeler code55910
First marketedFeb 2010
Product typeHuman Otc Drug
Portfolio139 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.

🧪 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 Brown
ShapeOval
Imprint20
Size12 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 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 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 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 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 5KV86114PT
    A chemical compound used in medicines as a pH buffer and neutralizing agent. It helps maintain the proper acidity level in liquid formulations to improve stability and make the medicine easier to take.
  • 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 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 QU7E2XA9TG
    Sodium stearate is a salt derived from stearic acid, a natural fatty substance. It acts as a lubricant and binder in tablets and capsules, helping the medicine hold together and flow smoothly during manufacturing.
  • 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 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.

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

The official label also statescarnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, 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 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 · 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: 1 tablet 1 tablet 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 mg 53943-0016-05 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 mgthis 55910-0915-03 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 —
Omeprazole 20 mg 53943-0038-14 Discount 14 tablets — — FDA listed —
Omeprazole 20 mg 72288-0934-01 Amazon.com 14 tablets — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2007
First FDA approval
Dec 2007
📍
2026
Currently FDA-listed
19 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 4, 2007 RLD RS ⏳ ~3.4 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 12599565 — drug product
2007 2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029
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 (1)
PatentTypeUse codeExpires
US 12599565 ↗ Drug product — Jan 31, 2030
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
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.

📊 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 NDCDescription Marketing startStatus
55910-0915-02 2 BOTTLE in 1 CARTON (55910-915-02) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2012-05-20 Active
55910-0915-03 You're viewing this 3 BOTTLE in 1 CARTON (55910-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 2013-07-24 Active
55910-0915-30 2 CARTON in 1 CARTON (55910-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2011-06-13 Discontinued by firm
55910-0915-74 14 BLISTER PACK in 1 CARTON (55910-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2010-02-14 Active

Pack size FAQ

What quantity is in NDC 55910-0915-03?
NDC 55910-0915-03 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 dg health omeprazole 20 mg Tablet, Delayed Release?
Bill NDC 55910-0915-03 — the 11-digit billing format is 55910091503. 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 ✓ 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 55910-915-03, 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: 55910-0915-03, written without dashes as 55910091503. 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 55910-0915-03, the first segment (55910) is the labeler code FDA assigned to Dolgencorp, LLC; the middle segment (0915) 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 Dolgencorp, LLC. 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 3 other package presentations of this same product, including 1 tablet (55910-0915-30), 1 tablet (55910-0915-74), 14 tablets (55910-0915-02). 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?
Dolgencorp, LLC 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 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 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 ~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).

📦 Storage and Handling 27 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) and protect from moisture

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Omeprazole 20 mg

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, 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 ↗
← 55910-0912-01 · DOLGENCORP, 55910-0916-16 · Dolgencorp, →
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.