Omeprazole
- Product NDC
- 55111-645
- 11-digit product format
- 551110645
- Labeler code
- 55111
- Product ID
- 55111-645_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2014-03-01
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 |
|---|---|---|---|---|---|---|---|
| A078490-001 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | |
| A078490-002 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | |
| A078490-003 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078490-001 | AB |
| A078490-002 | AB |
| A078490-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-002 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-003 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-03-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078490-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-04-17 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078490-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078490-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078490-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078490-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078490-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078490-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078490-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078490-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078490-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078490-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078490-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078490-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078490-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078490-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078490-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078490-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| KG60484QX9 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 603d2d06-c5e8-4378-a422-8dca1a410af7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 873ef493-6b37-49d8-ac7f-bfca4117d2c1 | Product name | 5 | 20210607 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-645-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 34 | |
| 55111-645-05 | Omeprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | 34 | |
| 55111-645-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 34 | |
| 55111-645-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 34 | |
| 55111-645-34 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 34 | |
| 55111-645-34 | Omeprazole | 12 in 1 CARTON | CAPSULE, DELAYED RELEASE | 12 | 34 | |
| 55111-645-78 | Omeprazole | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | 34 | |
| 55111-645-79 | Omeprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | 34 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-645-01 | EA - Each | 55111-645 | 09e3b832-5a8a-4207-948d-31ede49cd651 | 1 | 2014-04-03 |
| 55111-645-05 | EA - Each | 55111-645 | 15aede77-bf15-4e6a-8eff-77b81b3562aa | 1 | 2014-04-03 |
| 55111-645-10 | EA - Each | 55111-645 | 3a6ce06c-1b6d-4a33-92ab-d6f2e3982a87 | 1 | 2025-11-13 |
| 55111-645-30 | EA - Each | 55111-645 | 78d5bd3e-1bc4-4f75-b7c1-10707767ae95 | 1 | 2014-04-03 |
| 55111-645-34 | EA - Each | 55111-645 | 982fb8ee-42e8-4128-9902-628841bd5c06 | 1 | 2015-06-09 |
DailyMed Socrata Ingredients#
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 | PD-Rx Pharmaceuticals, Inc. | 96104ea6-c08f-40b5-83f5-d840b317f1fd | 2026-07-31 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | 0344268f-d8e6-48d5-b1e1-f750ed1d8a52 | 2026-07-17 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | St. Mary's Medical Park Pharmacy | 4c0cf466-f9e8-390e-e063-6294a90a2ed8 | 2026-07-02 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | e07af8c9-559c-5a93-e053-2a95a90a2c63 | 2026-03-11 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Dr. Reddy's Laboratories Limited | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 2026-03-02 | Warnings, Adverse reactions | 078490 ANDA078490 55111-645 |
| Omeprazole | OMEPRAZOLE | NorthStar Rx LLC | 40a75dc7-49b7-5c9d-6c5f-d4682ec6922e | 2026-03-02 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | REMEDYREPACK INC. | 63b3982a-b541-4b0d-99d4-93a673e57d46 | 2026-02-19 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | 288bdd5e-a0ac-4c5c-abe0-93183a28dcdd | 2026-01-20 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | 4720cc17-013e-074e-e063-6294a90ac1f4 | 2025-12-29 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Redpharm Drug | 2fd1acb8-12dc-70b7-e063-6394a90a0399 | 2025-12-25 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | American Health Packaging | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 2025-12-10 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals, Inc. | 28515ff8-379d-5356-e063-6394a90af3f3 | 2025-09-29 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 3724b8f7-52ff-a5f8-e063-6294a90acf20 | 2025-09-02 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Quallent Pharmaceuticals Health LLC | 8090d4c3-3184-7812-53d7-aa30e14b79d1 | 2025-08-10 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | PHOENIX RX LLC | 3b19d724-821b-61dc-e063-6294a90aa4d3 | 2025-07-29 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | 30955530-56d2-174d-e063-6294a90a413c | 2025-03-06 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 40f66cac-bc23-43f9-9966-87cce458c996 | 2025-02-17 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 2dcd48e4-9ffc-9cc2-e063-6294a90ae17e | 2025-02-10 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Coupler LLC | 2cdc6809-3b1b-046a-e063-6394a90ae02a | 2025-01-29 | Warnings, Adverse reactions | 078490 ANDA078490 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | a806da8c-5f84-454d-966c-da1c48710f80 | 2025-01-20 | Warnings, Adverse reactions | 078490 ANDA078490 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 0344268f-d8e6-48d5-b1e1-f750ed1d8a52 | 34 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 0344268f-d8e6-48d5-b1e1-f750ed1d8a52 | 34 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 603d2d06-c5e8-4378-a422-8dca1a410af7 | 34 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 205652e1-7fbc-4b6a-bbd6-2fd346d812df | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | f77efc97-2565-38ab-e053-6394a90aebda | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 288bdd5e-a0ac-4c5c-abe0-93183a28dcdd | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | f550f664-b74f-47f4-9063-0e4aff98b239 | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 4720cc17-013e-074e-e063-6294a90ac1f4 | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 288bdd5e-a0ac-4c5c-abe0-93183a28dcdd | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 4720cc17-013e-074e-e063-6294a90ac1f4 | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | f550f664-b74f-47f4-9063-0e4aff98b239 | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | f77efc97-2565-38ab-e053-6394a90aebda | 2 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | dec2cba8-3a85-6c79-e053-2a95a90aa088 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 2dcd48e4-9ffc-9cc2-e063-6294a90ae17e | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | dec2cba8-3a85-6c79-e053-2a95a90aa088 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 2dcd48e4-9ffc-9cc2-e063-6294a90ae17e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-645-01 | 55111064501 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-01) | 2014-03-01 | 0000-00-00 | No | No | Current | |
| 55111-645-05 | 55111064505 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-05) | 2014-03-01 | 0000-00-00 | No | No | Current | |
| 55111-645-10 | 55111064510 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-10) | 2025-10-01 | No | No | Current | ||
| 55111-645-30 | 55111064530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-645-30) | 2014-03-01 | 0000-00-00 | No | No | Current | |
| 55111-645-34 | 55111064534 | 12 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 12 bottle | 2015-05-14 | 0000-00-00 | No | No | Current |
| 55111-645-78 | 55111064578 | 10 BLISTER PACK in 1 CARTON (55111-645-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-645-79) | 10 blister pack | 2014-03-01 | 0000-00-00 | No | No | Current |
| 55111-645-79 | 55111064579 | 10 in 1 BLISTER PACK | Historical |