Application 075576
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
| 003 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075576-001 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | |
| A075576-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A075576-003 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075576-001 | AB |
| A075576-002 | AB |
| A075576-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075576-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075576-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075576-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075576-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075576-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075576-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075576-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075576-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075576-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075576-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075576-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075576-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075576-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075576-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075576-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075576-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075576-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075576-001 | AB | 1 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | St. Mary's Medical Park Pharmacy | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2026-06-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 2025-12-26 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | QPharma, Inc. | f5dcf0b2-4fa2-023a-e053-2995a90a183a | 2025-12-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quallent Pharmaceuticals Health LLC | 665e9877-85ac-fdb6-54ac-1c47941ceab8 | 2025-11-28 | Warnings, Adverse reactions | 075576 ANDA075576 82009-022 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 2025-10-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85e324-ef9f-196c-e053-2995a90a384e | 2024-12-31 | Warnings, Adverse reactions | 075576 ANDA075576 80425-0071 |
| Omeprazole | OMEPRAZOLE | Quality Care Products, LLC | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 2024-12-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | f0f61a89-700d-481d-9255-6f9a9afa7025 | 2024-10-01 | Warnings, Adverse reactions | 075576 ANDA075576 63187-805 |
| Omeprazole | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 2024-07-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | e1f20429-cfaa-420b-a65a-271be37eb799 | 2024-05-28 | Warnings, Adverse reactions | 075576 ANDA075576 71335-0332 |
| Omeprazole | OMEPRAZOLE | Dr. Reddy's Laboratories Limited | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 2024-04-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 2023-09-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | NorthStar Rx LLC | c5af5f4b-17be-7245-b281-f27c87831242 | 2023-06-20 | Warnings, Adverse reactions | 075576 ANDA075576 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55154-6648 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-8191 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-8191 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-8191 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-8191 | Omeprazole | Omeprazole | Cardinal Health 107, LLC | ANDA | Current |
| 58118-0158 | Omeprazole | Omeprazole | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0158 | Omeprazole | Omeprazole | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0158 | Omeprazole | Omeprazole | Clinical Solutions Wholesale | ANDA | Current |
| 63187-805 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-805 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-805 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-805 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63629-3643 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-3643 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-3643 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-3643 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 63629-4358 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 64725-0158 | Omeprazole | Omeprazole | TYA Pharmaceuticals | ANDA | Current |
| 67296-0706 | Omeprazole | Omeprazole | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0706 | Omeprazole | Omeprazole | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0706 | Omeprazole | Omeprazole | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2180 | Omeprazole | Omeprazole | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2180 | Omeprazole | Omeprazole | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2180 | Omeprazole | Omeprazole | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2180 | Omeprazole | Omeprazole | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4051 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4051 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4051 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-128 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-128 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-128 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-128 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-128 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-466 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-466 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-466 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68084-466 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68788-1554 | Omeprazole | Omeprazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69181-158 | Omeprazole | Omeprazole | Midwest Drug Distribution, Inc. | ANDA | Current |
| 70518-0056 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0056 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0080 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0754 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0754 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1209 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1209 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-118 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-118 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-773 | Omeprazole | Omeprazole | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-0332 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0332 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0332 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0332 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 75921-158 | Omeprazole | Omeprazole | Life Line Home Care Services, Inc. | ANDA | Current |
| 80175-0715 | Omeprazole | Omeprazole | Central Packaging | ANDA | Current |
| 80175-0715 | Omeprazole | Omeprazole | Central Packaging | ANDA | Current |
| 80425-0071 | Prilosec | Omeprazole 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0071 | Prilosec | Omeprazole 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0071 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0071 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0071 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 82009-022 | Omeprazole | Omeprazole | Quallent Pharmaceuticals Health LLC | ANDA | Current |