Active ingredient
Omeprazole
356 finished FDA listings contain Omeprazole as their only active ingredient; 38 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- OMEPRAZOLE, OMEPRAZOLE MAGNESIUM
- Dosage forms
- Capsule, Capsule, Delayed Release, Capsule, Delayed Release Pellets, Granule, Delayed Release, Tablet, Delayed Release, Tablet, Orally Disintegrating, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 145
- Strengths listed
- 10 mg/1 · 2.5 mg/1 · 20 mg/1 · 20.6 mg/1 · 40 mg/1
- Brand names in FDA listings
- 24 Hour Omeprazole, 24 Hr Omeprazole, Acid Reducer, Amazon Basic Care Omeprazole, Basic Care Omeprazole, Berkley And Jensen Omeprazole, Care One Omeprazole, Careone Omeprazole, Dg Health Omeprazole, Dg Health Omperazole, Equaline Omeprazole, Equate Omeprazole, Equate Omeprazole Delayed Release Acid Reducer, Exchange Select Omeprazole, Foster And Thrive Omeprazole, Good Neighbor Pharmacy Omeprazole, Good Now Omeprazole, Good Sense Omeprazole, Good Sense Omeprazole Delayed Release, Goodmeds 24hr Acid Reducer Omeprazole 20mg, Kirkland Signature Omeprazole, Leader Omeprazole, Members Mark Omeprazole, Omeprazole, Omeprazole Delayed Release, Omeprazole Delayed-Release, Omeprazole Dr, Omeprazole Magnesium, Omeprazole, 24/7 Life By 7-Eleven, Prilosec, Prilosec Otc, Rugby Omeprazole, Signature Care Omeprazole, Topcare Omeprazole, Topcare Omeprazole Delayed Release, Up And Up Omeprazole
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7646
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075410 | LANNETT CO INC | 2002-11-01 | 12 |
| ANDA 075757 | SANDOZ | 2003-01-28 | 11 |
| NDA 021229 | ASTRAZENECA | 2003-06-20 | 2 |
| ANDA 075576 | DR REDDYS LABS LTD | 2007-10-22 | 15 |
| ANDA 076048 | APOTEX | 2007-10-22 | 11 |
| NDA 022032 | DEXCEL PHARMA | 2007-12-04 | 59 |
| NDA 022056 | AZURITY | 2008-03-20 | 2 |
| ANDA 076515 | SANDOZ | 2009-01-21 | 1 |
| ANDA 078490 | DR REDDYS LABS LTD | 2009-04-17 | 35 |
| ANDA 078878 | DR REDDYS LABS LTD | 2009-06-05 | 14 |
| ANDA 091352 | ZYDUS PHARMS USA INC | 2012-11-19 | 12 |
| ANDA 091672 | GLENMARK PHARMS LTD | 2014-10-31 | 33 |
| ANDA 203270 | AUROBINDO PHARMA | 2015-08-19 | 21 |
| ANDA 203481 | BRECKENRIDGE | 2017-07-03 | 3 |
| NDA 209400 | DEXCEL | 2017-07-05 | 18 |
| ANDA 206877 | AUROBINDO PHARMA | 2018-06-06 | 20 |
| ANDA 210593 | SPIL | 2018-07-20 | 6 |
| ANDA 207891 | SUN PHARM | 2018-10-12 | 15 |
| ANDA 207740 | DR REDDYS | 2018-11-05 | 7 |
| ANDA 204012 | HETERO LABS LTD III | 2019-09-26 | 2 |
| ANDA 211732 | HETERO LABS LTD III | 2020-03-25 | 5 |
| ANDA 206582 | P AND L | 2020-06-01 | 14 |
| ANDA 212977 | XIROMED | 2020-12-10 | 17 |
| ANDA 216096 | DEXCEL | 2022-05-24 | 14 |
| ANDA 213201 | AUROBINDO PHARMA LTD | 2023-04-28 | 1 |
| ANDA 218829 | PHARMAZONE | 2025-08-07 | 5 |
Official labeling on DailyMed
- OMEPRAZOLE TABLET, DELAYED RELEASE [RITE AID CORPORATION] · version 4 · 2026-09-10
- OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [YYBA CORP] · version 2 · 2026-09-02
- OMEPRAZOLE TABLET, DELAYED RELEASE [AMAZON.COM SERVICES LLC] · version 2 · 2026-09-02
- OMEPRAZOLE TABLET, DELAYED RELEASE [DISCOUNT DRUG MART, INC] · version 2 · 2026-09-02
- OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.] · version 8 · 2026-08-31
- AMAZON BASIC CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [AMAZON.COM SERVICES LLC] · version 3 · 2026-08-31
- OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] · version 1 · 2026-08-28
- GOOD NOW OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [GOBRANDS, INC] · version 3 · 2026-08-20
- OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B] · version 2 · 2026-08-19
- GOODMEDS 24HR ACID REDUCER OMEPRAZOLE 20MG (OMEPRAZOLE 20MG) TABLET, DELAYED RELEASE [CABINET HEALTH P.B.C.] · version 1 · 2026-08-17
- OMEPRAZOLE 20 MG TABLET, DELAYED RELEASE [MARKSANS PHARMA LIMITED] · version 2 · 2026-08-07
- OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.] · version 12 · 2026-08-07
Showing the 12 most recent of 311 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.