Who makes Kirkland Signature Omeprazole 20 mg Delayed-Release Tablets (42 Count)?
As of August 30, 2026, evidence points to Dexcel Pharma as the manufacturer of Kirkland Signature Omeprazole 20 mg Delayed-Release Tablets (42 Count), but no tier 1–3 source names the link directly.
The common claim
What most answers say — and what the evidence supports
Roundups and AI answers for "who makes Kirkland omeprazole" tend to assume Costco's version is simply Prilosec OTC under a cheaper label, or to credit Perrigo, the large private-label drugmaker, without saying how. FDA records and Perrigo's own announcements show the Perrigo answer is half the chain. The Kirkland Signature Omeprazole 20 mg delayed-release tablets (NDC 63981-915) are marketed not under a generic ANDA - the usual store-brand route - but under a full New Drug Application, NDA022032, whose Drugs@FDA holder is Dexcel Pharma, an Israeli specialty drugmaker, first approved in December 2007. That single application supplies dozens of retailers' omeprazole (Walmart Equate, Target Up & Up, Amazon Basic Care, Sam's Member's Mark and more), and the FDA-approved labeling for NDA 22-032 carries a "Manufactured by: Dexcel Pharma Technologies Ltd., Yokneam, Israel - Made in Israel" block, so per that FDA-approved labeling (2016) the tablets are made in Israel. Perrigo's part is supply, not manufacture: in November 2007 Perrigo announced it would be "the exclusive marketer and distributor for the store brand over-the-counter market in the United States of the Dexcel-developed and manufactured product," and Perrigo's own Good Sense omeprazole (NDC 0113-0915) sits under the same NDA. Consistent with that, Costco's own product listing for the 42-count item carries "L Perrigo Company" in its manufacturer field - the supplier of record, not the plant. Prilosec OTC is a separate product - a Procter & Gamble brand marketed under its own application (NDA021229) and formulated as omeprazole magnesium rather than plain omeprazole - so despite the "Compare to Prilosec OTC" box, Costco's version is not the Prilosec maker's product. Because the maker is reached through the NDC-to-NDA-to-sponsor join and an application holder is not always the physical packer of every lot, the evidence points to Dexcel Pharma as the manufacturer - with Perrigo as the store-brand supplier - without rising to a flat confirmation.
Evidence & sources
Every source is graded on the six-tier rubric and archived, so the citation holds even if the original moves or paywalls. The tier badge grades the source; the status grades our confidence in the maker.
Tier 3
DailyMed's FDA-sourced label "KIRKLAND SIGNATURE OMEPRAZOLE- omeprazole tablet, delayed release" names Costco Wholesale Company as the labeler, lists NDC 63981-915(-55) (omeprazole 20 mg delayed-release, 42 tablets = three 14-day courses, principal display panel reads "Compare to Prilosec OTC"; marketing start 2008-02-27), and in Marketing Information gives Marketing Category "New Drug Application" with Application Number NDA022032. That is an NDA, not the ANDA most store-brand OTCs carry. No establishment other than Costco appears on the SPL, so the maker is reached through the NDA number (resolved to Dexcel Pharma in the sibling Drugs@FDA source).
Tier 3
FDA's Drugs@FDA resolves NDA022032 - the application behind Kirkland Signature Omeprazole (NDC 63981-915) - to sponsor DEXCEL PHARMA, product OMEPRAZOLE, dosage form "TABLET, DELAYED RELEASE", route ORAL, omeprazole 20 mg, marketing status Over-the-counter; original approval 2007-12-04, submission classification "Type 5 - New Formulation or New Manufacturer", and it is flagged a reference-listed drug. The record's openfda block shows this single NDA is shared across dozens of store brands (Costco Kirkland Signature, Walmart Equate, Target Up & Up, Amazon Basic Care, Sam's Member's Mark, CVS, Walgreens, Kroger, Rite Aid and others). Graded probable, not confirmed: openFDA's NDC manufacturer_name only echoes the labeler (Costco), so the maker is reached through the NDC->NDA->sponsor join; an application holder is FDA's responsible party but not guaranteed to be the physical packer of every lot - though an NDA holder (unlike an ANDA distributor) is a tighter link, and the NDA's own approved labeling independently names Dexcel as manufacturer (see the FDA labeling source).
Tier 3
The FDA-approved carton/label artwork filed under NDA 22-032 (Omeprazole Delayed Release Tablets, 20 mg) carries the manufacturer block "Manufactured by: Dexcel Pharma Technologies Ltd. 10 Hakidma Street, Yokneam, 20692, Israel" alongside the statement "Made in Israel." This is the NDA's own reference labeling (this specific artwork is the Wildberry Mint variant within NDA 22-032; the Dexcel manufacturer block is common to the application, and Costco's plain tablets carry the same NDA). Store-brand SPLs such as Kirkland's name only the Costco distributor, so this application labeling is where the physical maker and country of origin (Israel) are documented rather than on the Kirkland carton.
Tier 4
Perrigo's own 2007 announcement of the store-brand omeprazole supply arrangement: "Perrigo will be the exclusive marketer and distributor for the store brand over-the-counter market in the United States of the Dexcel-developed and manufactured product," and, of its partner, "Headquartered in Or Akiva, Israel, Dexcel Pharma Technologies, Ltd. is a privately-held, international specialty pharmaceutical company" engaged in development, manufacture and marketing. It documents Perrigo's role as the US store-brand distributor of Dexcel's tablets and, in Perrigo's own words, names Dexcel as the developer and manufacturer. It does not name Kirkland or Costco, so it is context for the supply chain rather than a brand-link source; the tier-3 FDA records above anchor the attribution. Perrigo's Good Sense omeprazole (NDC 0113-0915, marketed since 2008-02-28) is listed under the same NDA022032 in the FDA NDC directory, the way Costco's other Perrigo-supplied acid reducers mirror Perrigo's product codes.
Tier 4
Costco's Business Delivery storefront (costcobusinessdelivery.com) serves the same US catalog data as costco.com and, unlike costco.com, can be fetched and archived. Its page for this item - 'Kirkland Signature Omeprazole Acid Reducer Tablets, 20 mg Delayed-Release Tablets, 42 ct' (item 2001114475) - embeds catalog JSON whose manufacturer field reads mfName: "L PERRIGO COMPANY", L. Perrigo Company being Perrigo's principal US operating company (Allegan, MI). Read on August 30, 2026 and verified present in the Wayback snapshot created the same day. Context, not the attribution: the field is an internal catalog entry that can name a supplier-of-record rather than the plant, and here it does exactly that. Perrigo, by its own 2007 announcement (source above), is the exclusive US store-brand marketer and distributor of Dexcel's omeprazole tablets, so Costco's vendor of record for this item is Perrigo, while the FDA-approved labeling for NDA 022032 names Dexcel Pharma Technologies as the manufacturer and Israel as the country of origin. The field therefore corroborates the record's existing framing - Dexcel makes, Perrigo supplies - rather than competing with it, and it does not move the grade: the tier-3 FDA records anchor the attribution and the status stays probable.
Frequently asked
Who makes Kirkland Signature omeprazole for Costco?
Is Kirkland omeprazole the same as Prilosec?
Why is Kirkland omeprazole a brand-name NDA instead of a generic?
Where are Kirkland omeprazole tablets made?
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