Omeprazole
- Product NDC
- 68462-396
- 11-digit product format
- 684620396
- Labeler code
- 68462
- Product ID
- 68462-396_69b1e229-f845-4608-be48-f97e8d3e2273
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091672-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | |
| A091672-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 |
| A091672-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091672-001 | AB |
| A091672-002 | AB |
| A091672-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091672-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| KG60484QX9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6c22be1-659d-4e71-b292-701e27da201b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 873ef493-6b37-49d8-ac7f-bfca4117d2c1 | Product name | 5 | 20210607 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-396-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 14 | |
| 68462-396-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 14 | |
| 68462-396-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 14 | |
| 68462-396-90 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-396-01 | EA - Each | 68462-396 | ac9c1283-556e-4a6a-9419-087658aafb81 | 1 | 2016-10-06 |
| 68462-396-10 | EA - Each | 68462-396 | e1ad3712-cc24-4038-a896-822eea62be5d | 1 | 2016-10-06 |
| 68462-396-30 | EA - Each | 68462-396 | 42e1dc7b-ec4a-4433-ab85-8d0d731deb86 | 1 | 2016-10-06 |
| 68462-396-90 | EA - Each | 68462-396 | eca1bb0b-d1cb-48fc-b8ec-e6e4271b7f19 | 1 | 2016-10-06 |
DailyMed Dashboard NDC Coverage#
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 | REMEDYREPACK INC. | a19ce586-59b7-4c2e-9e8d-12e8f0f058e2 | 2026-07-21 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | HAWAII REPACK, INC. | 9359e826-5263-44fc-8dd3-9d0852fe42d6 | 2026-07-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | dcaadc8c-32d1-476f-b821-973c012b7fa7 | 2026-07-10 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Unit Dose Solutions, Inc. | 557d4c2c-5541-3a51-e063-6394a90ad278 | 2026-06-30 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | REMEDYREPACK INC. | d9b3918c-a66e-4277-8b8f-b7ece93fa7db | 2026-06-24 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | ST. MARY'S MEDICAL PARK PHARMACY | 4f5c91e6-6377-ca94-e063-6294a90a2f99 | 2026-04-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx Pharmacy of Tennessee, LLC | c8bf92c9-1bab-7985-e053-2995a90a0225 | 2026-03-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Glenmark Pharmaceuticals Inc., USA | c6c22be1-659d-4e71-b292-701e27da201b | 2026-01-19 | Warnings, Adverse reactions | 091672 ANDA091672 68462-396 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | fa0395a7-4353-4d64-9de8-d15857a7031c | 2026-01-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 17ccdbe0-19c1-498d-8e81-578be549b4e5 | 2025-12-02 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | aa8fc2ea-3942-453b-bc19-1e4b14ba6926 | 2025-09-03 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 3d6e07d1-38b1-f2ab-e063-6294a90a34ac | 2025-08-28 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | bab55f83-ba03-49a0-842a-19c9976b7fe8 | 2025-08-28 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 5bda70ae-c3f6-450b-892f-6814795dd6ca | 2025-08-18 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | PHOENIX RX LLC | 3a9baece-03be-6c77-e063-6394a90a7032 | 2025-07-23 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Asclemed USA, Inc. | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 2025-02-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | NCS HealthCare of KY, LLC dba Vangard Labs | d1e0c8fc-1f15-45a4-a80f-653a1dae5e56 | 2025-01-16 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85afda-6b0c-d657-e053-2a95a90afb4b | 2024-12-31 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 30e58465-c5d2-4925-85bb-53faa6135c5c | 2024-09-05 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 5ad413ed-a21b-4f8b-9322-8fbb813b14d3 | 2024-09-01 | Warnings, Adverse reactions | 091672 ANDA091672 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | a19ce586-59b7-4c2e-9e8d-12e8f0f058e2 | 16 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | a19ce586-59b7-4c2e-9e8d-12e8f0f058e2 | 16 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | a19ce586-59b7-4c2e-9e8d-12e8f0f058e2 | 16 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | c6c22be1-659d-4e71-b292-701e27da201b | 14 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 5bda70ae-c3f6-450b-892f-6814795dd6ca | 12 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 5bda70ae-c3f6-450b-892f-6814795dd6ca | 12 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 5bda70ae-c3f6-450b-892f-6814795dd6ca | 12 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | aa8fc2ea-3942-453b-bc19-1e4b14ba6926 | 10 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | af85afda-6b0c-d657-e053-2a95a90afb4b | 10 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | aa8fc2ea-3942-453b-bc19-1e4b14ba6926 | 10 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | af85afda-6b0c-d657-e053-2a95a90afb4b | 10 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | af85afda-6b0c-d657-e053-2a95a90afb4b | 10 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | aa8fc2ea-3942-453b-bc19-1e4b14ba6926 | 10 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | f43f6cee-7609-4ca0-a409-e4a74575a277 | 8 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | f43f6cee-7609-4ca0-a409-e4a74575a277 | 8 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | f43f6cee-7609-4ca0-a409-e4a74575a277 | 8 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 2d99b4fd-49b3-403d-96a4-0cceda85a95c | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 2d99b4fd-49b3-403d-96a4-0cceda85a95c | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 2d99b4fd-49b3-403d-96a4-0cceda85a95c | 7 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 7 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 17ccdbe0-19c1-498d-8e81-578be549b4e5 | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 17ccdbe0-19c1-498d-8e81-578be549b4e5 | 6 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 17ccdbe0-19c1-498d-8e81-578be549b4e5 | 6 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 6 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 87e91beb-e8ed-17ac-e053-2995a90a4ba8 | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 87e91beb-e8ed-17ac-e053-2995a90a4ba8 | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 87e91beb-e8ed-17ac-e053-2995a90a4ba8 | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 5564c9dc-6f99-6639-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 5564c9dc-6f99-6639-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 5564c9dc-6f99-6639-e054-00144ff8d46c | 4 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 6cceb8a3-d35a-f3e0-e053-2991aa0a6360 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | dcaadc8c-32d1-476f-b821-973c012b7fa7 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 6cceb8a3-d35a-f3e0-e053-2991aa0a6360 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | dcaadc8c-32d1-476f-b821-973c012b7fa7 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 6cceb8a3-d35a-f3e0-e053-2991aa0a6360 | 3 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | dcaadc8c-32d1-476f-b821-973c012b7fa7 | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 5269d44f-ae9b-3a34-e054-00144ff8d46c | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 5269d44f-ae9b-3a34-e054-00144ff8d46c | 2 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 5269d44f-ae9b-3a34-e054-00144ff8d46c | 2 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 3d6e07d1-38b1-f2ab-e063-6294a90a34ac | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 3a9baece-03be-6c77-e063-6394a90a7032 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | de384c26-bae0-2adc-e053-2a95a90ad0fd | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 3d6e07d1-38b1-f2ab-e063-6294a90a34ac | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | de384c26-bae0-2adc-e053-2a95a90ad0fd | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 3a9baece-03be-6c77-e063-6394a90a7032 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 3a9baece-03be-6c77-e063-6394a90a7032 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 3d6e07d1-38b1-f2ab-e063-6294a90a34ac | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | de384c26-bae0-2adc-e053-2a95a90ad0fd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68462-396-01 | 68462039601 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-01) | 2016-10-01 | 0000-00-00 | No | No | Current |
| 68462-396-10 | 68462039610 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-10) | 2016-10-01 | 0000-00-00 | No | No | Current |
| 68462-396-30 | 68462039630 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-30) | 2016-10-01 | 0000-00-00 | No | No | Current |
| 68462-396-90 | 68462039690 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-90) | 2016-10-01 | 0000-00-00 | No | No | Current |