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Omeprazole 20 mg Capsule, Delayed Release, 14-count — NDC 58602-0837-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Omeprazole 20 mg Capsule, Delayed Release, 14-count — NDC 58602-837-05 (Billing 58602-0837-05)

by Aurohealth LLC · 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 14 capsules of Omeprazole 20 mg Capsule, Delayed Release from Aurohealth LLC, marketed since Apr 2023 and currently FDA-listed. It is this product's only package size.

NDC 58602-0837-05
🏷️ FDA NDC (as labeled) 58602-837-05 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-837-05
Product NDC 58602-837
11-digit billing NDC 58602083705
RxCUI 198051
UNII 426QFE7XLK
UPC 0358602837051
Application # ANDA213201
SPL Set ID 19097902-a5e6-423a-8569-31c569cd3cdb
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 2023-04-28
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM
Quick answers
  • RxCUI (RxNorm): 198051
Why two NDCs? The FDA registers this code as 58602-837-05 — 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 → 58602-0837-05. 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.

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
  • It lowers stomach acid. Prescription versions treat ulcers, GERD, erosive esophagitis and H. pylori infection. Over-the-counter versions treat frequent heartburn, which is heartbur...
  • Take it by mouth once a day, before eating. For over-the-counter use, that means the morning, with water, for a 14-day course. Swallow capsules and regular tablets whole. Dissolvin...
  • It is not for immediate relief. The over-the-counter label says full effect can take 1 to 4 days. Some people feel complete relief within 24 hours.
  • The most common are headache, stomach pain, nausea, diarrhea, vomiting and gas. Call your doctor for diarrhea that does not go away, new rash or joint pain, or signs of an allergic...
📖 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.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2027 $2.84 / 14 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58602-0837-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2023-04-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Omeprazole 20 mg 16714-0715-01 NorthStar 30 capsules $0.028 AB Discontinued —
Omeprazole 20 mg 60505-0065-00 Apotex 30 capsules $0.028 AB Discontinued —
Omeprazole 20 mg 68084-0128-01 American 1 capsule $0.028 AB Discontinued —
Omeprazole 20 mg 00781-2868-01 Sandoz 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 00904-6917-61 Major 1 capsule $0.029 AB Availability likely —
Omeprazole 20 mg 16714-0634-01 NorthStar 30 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 55111-0158-01 Dr. 100 capsules $0.029 — Availability likely —
Omeprazole 20 mg 55111-0644-01 Dr. 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 60687-0597-01 American 1 capsule $0.029 AB Availability likely —
Omeprazole 20 mg 68382-0412-01 Zydus 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 68462-0396-01 Glenmark 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 82009-0022-10 Quallent 1000 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 82009-0183-10 Quallent 1000 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 60505-3952-03 Apotex 30 capsules $0.034 AB Discontinued —
Omeprazole 20 mg 62175-0118-32 Lannett 30 capsules $0.036 AB FDA listed —
Omeprazole Magnesium 20 mg 55111-0397-27 Dr. 14 capsules $0.395 — Availability likely —
Acid Reducer 20 mg 70000-0232-01 LEADER/ 14 capsules $0.395 — Availability likely —
Omeprazole Magnesium 20 mg 83324-0117-14 Chain 14 capsules $0.395 — Availability likely —
Omeprazole 20.6 mg 46122-0686-03 AMERISOURCE 14 capsules $0.408 — Discontinued —
Omeprazole Magnesium 20 mg 00363-0042-01 Walgreens 14 capsules — — FDA listed —
Omeprazole 20 mg 00363-4099-03 Walgreen 14 capsules — — FDA listed —
omeprazole 20 mg 00363-6089-01 Walgreen 14 capsules — — FDA listed —
Omeprazole 20 mg 00363-9980-14 Walgreen 14 capsules — — FDA listed —
Omeprazole 20 mg 00615-8406-05 NCS 15 capsules — AB FDA listed —
Omeprazole 20 mg 00781-2790-01 Sandoz 100 capsules — AB FDA listed —
Omeprazole 20 mg 11673-0948-14 UP 14 capsules — — FDA listed —
omeprazole 20.6 mg 11822-0061-04 Rite 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 21130-0398-33 Albertsons 14 capsules — — FDA listed —
omeprazole 20 mg 21130-0528-01 Safeway 14 capsules — — FDA listed —
Omeprazole 20 mg 21130-0783-01 Safeway 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 30142-0012-01 The 14 capsules — — FDA listed —
omeprazole 20 mg 31722-0528-01 Camber 100 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 37808-0006-33 HEB 14 capsules — — FDA listed —
Omeprazole 20 mg 42708-0170-14 QPharma 14 capsules — AB FDA listed —
Omeprazole 20 mg 42708-0199-14 QPharma 14 capsules — AB FDA listed —
Omeprazole 20 mg 43063-0743-14 PD-Rx 14 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 43598-0813-14 Dr. 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 49035-0397-27 Wal-Mart 14 capsules — — FDA listed —
Omeprazole 20 mg 49999-0265-14 Quality 14 capsules — AB Discontinued —
Omeprazole 20 mg 50090-1157-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-3876-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5111-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5901-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5902-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7018-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7019-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7021-00 A-S 1 capsule — AB FDA listed —
Omeprazole 20 mg 50090-7213-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7214-00 A-S 100 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7215-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7472-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7473-00 A-S 100 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7474-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 51316-0061-28 CVS 28 capsules — — FDA listed —
omeprazole 20 mg 51316-0271-03 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 51316-0843-03 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 51407-0287-01 Golden 100 capsules — AB Discontinued —
Omeprazole 20 mg 51407-0641-00 Golden 1 capsule — AB FDA listed —
Omeprazole 20 mg 51407-0813-01 Golden 100 capsules — AB FDA listed —
Omeprazole 20 mg 51655-0061-25 Northwind 60 capsules — AB FDA listed —
Omeprazole 20 mg 51655-0893-25 Northwind 60 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 53943-0520-14 Discount 14 capsules — — FDA listed —
Omeprazole 20 mg 55154-2332-00 Cardinal 1 capsule — AB FDA listed —
Omeprazole 20 mg 57237-0161-01 Rising 100 capsules — AB FDA listed —
omeprazole 20.6 mg 57483-0740-42 INNOVUS 14 capsules — — FDA listed —
Omeprazole Magnesium 20.6 mg 57896-0759-14 Gericare 14 capsules — — FDA listed —
Omeprazole 20 mgthis 58602-0837-05 Aurohealth 14 capsules — — FDA listed —
Omeprazole 20 mg 59651-0002-01 Aurobindo 100 capsules — — FDA listed —
Omeprazole 20 mg 60760-0747-07 St. 7 capsules — AB FDA listed —
Omeprazole 20 mg 60760-0833-30 St. 30 capsules — AB FDA listed —
Omeprazole 20 mg 60760-0868-07 St. 7 capsules — AB FDA listed —
Omeprazole 20 mg 63187-0070-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 20 mg 63187-0820-06 Proficient 6 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 63868-0177-15 Chain 14 capsules — — FDA listed —
Omeprazole 20 mg 65841-0760-01 Zydus 100 capsules — AB FDA listed —
Omeprazole 20 mg 67046-1509-03 Coupler 30 capsules — AB FDA listed —
Omeprazole 20 mg 67296-1939-03 Redpharm 30 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 68016-0760-14 Chain 14 capsules — — FDA listed —
Omeprazole 20 mg 68071-2243-07 NuCare 7 capsules — AB FDA listed —
Omeprazole 20 mg 68071-2262-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68071-3007-02 NuCare 28 capsules — AB FDA listed —
Omeprazole 20 mg 68071-3733-02 NuCare 20 capsules — AB FDA listed —
Omeprazole 20 mg 68071-4024-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68071-4025-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68788-4104-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-6881-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-8805-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-8864-01 Preferred 100 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 69842-0027-01 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 70518-2251-00 REMEDYREPACK 30 capsules — AB Discontinued —
Omeprazole 20 mg 70518-3278-00 REMEDYREPACK 30 capsules — AB Discontinued —
Omeprazole 20 mg 70518-4177-00 REMEDYREPACK 30 capsules — AB FDA listed —
Omeprazole 20 mg 70700-0150-00 Xiromed, 1 capsule — AB FDA listed —
Omeprazole 20 mg 71205-0613-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 20 mg 71205-0907-00 Proficient 100 capsules — AB FDA listed —
Omeprazole 20 mg 71335-0332-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-0569-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1636-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1746-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1852-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-9609-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0663-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0912-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0942-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0963-60 Aphena 90 capsules — AB FDA listed —
basic care omeprazole 20 mg 72288-0023-03 Amazon.com 42 capsules — — FDA listed —
omeprazole 20 mg 72288-0606-03 Amazon.com 14 capsules — — FDA listed —
Omeprazole 20 mg 72789-0482-14 PD-Rx 14 capsules — AB FDA listed —
Omeprazole 20 mg 76420-0055-03 Asclemed 30 capsules — AB FDA listed —
Omeprazole 20.6 mg 79481-0061-03 Meijer 42 capsules — — FDA listed —
omeprazole 20 mg 79481-0281-00 Meijer, 14 capsules — — FDA listed —
omeprazole 20 mg 79481-3023-01 Meijer, 14 capsules — — FDA listed —
equate omeprazole 20 mg 79903-0112-14 WALMART 14 capsules — — FDA listed —
Omeprazole DR 20 mg 80425-0070-01 Advanced 30 capsules — AB FDA listed —
Omeprazole DR 20 mg 80425-0071-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 80425-0415-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 80425-0504-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 82868-0043-60 Northwind 60 capsules — AB FDA listed —
Omeprazole 20 mg 83209-0150-05 Boswell 5 capsules — AB FDA listed —
Omeprazole 20 mg 85509-1396-01 PHOENIX 120 capsules — AB FDA listed —
Omeprazole 20 mg 85509-1644-01 PHOENIX 120 capsules — AB FDA listed —
Good Sense Omeprazole 20 mg 00113-6010-03 L. 14 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color Pink / White
ShapeCapsule
ImprintOZM;20
Size21 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 5KY68S2577
    A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statesblack iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], 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.

Manufacturer & labeler

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA213201 (ANDA)
Labeler code58602
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 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 46 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

⚠️ Warnings 53 words ▾

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.

If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 18 words ▾

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

🧪 Inactive Ingredients 63 words ▾

Inactive ingredients black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.

🎯 Purpose 3 words ▾

Purpose Acid reducer

📄 Do Not Use 58 words ▾

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 36 words ▾

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 22 words ▾

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 46 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

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)

📄 Package Label / Principal Display Panel 122 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Bottle) AUROHEALTH NDC 58602-837-05 See current Drug Facts Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR 14 Capsules One 14-Day Course of Treatment May take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label AUROHEALTH NDC 58602-837-05 See current Drug Facts *Compare to the active ingredient in Prilosec OTC ® Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn ! 24 HR OZM 20 14 Capsules One 14-Day Course of Treatment May Take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

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

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

Medicare Part D (outpatient prescription) spending for Omeprazole — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Omeprazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$75.01M
Claims incl. refills
7.1M
Beneficiaries
5.3M
Spend / beneficiary
$14.18
Spend / claim
$10.59
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurohealth 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.
← 58602-0836-07 · Aurohealth 58602-0838-14 · Aurohealth →
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.