Omeprazole
- Product NDC
- 62175-136
- 11-digit product format
- 621750136
- Labeler code
- 62175
- Product ID
- 62175-136_e786b865-dc62-4018-9cb1-7056b7ca2cde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2009-01-23
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075410-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | |
| A075410-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | |
| A075410-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075410-001 | AB |
| A075410-002 | AB |
| A075410-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075410-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075410-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075410-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | Chartwell RX, LLC | 10f5502a-2e63-4f2a-a3ba-ddc5bd403051 | 2025-12-22 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | ed9895ae-3d18-434c-8b56-47bccdc8fe6d | 2025-10-08 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | ad675ef6-5377-b9f2-e053-2995a90a06e9 | 2024-07-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 55a1fb3c-f040-2e39-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 8991d464-7abc-4350-e053-2995a90a4ea7 | 2024-06-14 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 1318a1c1-222d-471a-92d6-3632c82fb999 | 2024-05-24 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 18f5a7cc-40d8-4aeb-a601-47bc9024f130 | 2024-05-23 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | Lannett Company, Inc. | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 2023-04-21 | Warnings, Adverse reactions | 075410 ANDA075410 62175-136 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 9786b04f-f827-460b-91bc-c0ac967f95dd | 2022-11-01 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 4b188d97-f1b3-468d-9818-b8333bf24b5a | 2020-12-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 92201fb1-4570-42db-8da3-3b8c0e291d32 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 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 |
|---|---|---|---|---|---|---|
| 62175-136-32 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 50 | |
| 62175-136-37 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | 50 | |
| 62175-136-43 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 50 | |
| 62175-136-46 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 50 | |
| 62175-136-49 | Omeprazole | 36000 in 1 DRUM | CAPSULE, DELAYED RELEASE | 36000 | 50 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62175-136-32 | EA - Each | 62175-136 | 1a5a1f98-e561-4ca9-a588-0fb7782acf45 | 1 | 2012-07-24 |
| 62175-136-37 | EA - Each | 62175-136 | 0c41e231-8f2a-4e3f-b8af-6206e6047b52 | 1 | 2012-07-24 |
| 62175-136-43 | EA - Each | 62175-136 | 8cdd64dd-0726-4e89-aa3b-6902c1718777 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | ed9895ae-3d18-434c-8b56-47bccdc8fe6d | 50 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | ed9895ae-3d18-434c-8b56-47bccdc8fe6d | 50 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 50 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 0d3e1664-078f-4761-9fe2-fee36d6262f1 | 10 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 0d3e1664-078f-4761-9fe2-fee36d6262f1 | 10 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | PSN | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 9786b04f-f827-460b-91bc-c0ac967f95dd | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 1318a1c1-222d-471a-92d6-3632c82fb999 | 5 |
| 199119 | omeprazole 10 MG Delayed Release Oral Capsule | SCD | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 9786b04f-f827-460b-91bc-c0ac967f95dd | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 1318a1c1-222d-471a-92d6-3632c82fb999 | 5 |
| 199119 | omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule | SY | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | 5aba19da-663f-4901-94e2-f438dba4841f | 5 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 716841e8-83b7-4f0c-82c1-77a19cbef69f | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 8991d464-7abc-4350-e053-2995a90a4ea7 | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 4b188d97-f1b3-468d-9818-b8333bf24b5a | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | 1ba0fa57-b5a5-4e6a-9902-654d3aefc71f | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 8991d464-7abc-4350-e053-2995a90a4ea7 | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 716841e8-83b7-4f0c-82c1-77a19cbef69f | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 4b188d97-f1b3-468d-9818-b8333bf24b5a | 3 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | 1ba0fa57-b5a5-4e6a-9902-654d3aefc71f | 3 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | PSN | a140eda6-78ab-b5fc-e053-2a95a90a0d90 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | a140eda6-78ab-b5fc-e053-2a95a90a0d90 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | PSN | f03f6191-45cd-4c20-8bd5-783cb28d26c8 | 1 |
| 198051 | omeprazole 20 MG Delayed Release Oral Capsule | SCD | a140eda6-78ab-b5fc-e053-2a95a90a0d90 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | a140eda6-78ab-b5fc-e053-2a95a90a0d90 | 1 |
| 200329 | omeprazole 40 MG Delayed Release Oral Capsule | SCD | f03f6191-45cd-4c20-8bd5-783cb28d26c8 | 1 |
| 198051 | omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule | SY | a140eda6-78ab-b5fc-e053-2a95a90a0d90 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62175-136-32 | 62175013632 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-32) | 2009-01-23 | 0000-00-00 | No | No | Current |
| 62175-136-37 | 62175013637 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-37) | 2009-01-23 | 0000-00-00 | No | No | Current |
| 62175-136-43 | 62175013643 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-43) | 2009-01-23 | 0000-00-00 | No | No | Current |
| 62175-136-46 | 62175013646 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-46) | 2009-01-23 | 0000-00-00 | No | No | Current |
| 62175-136-49 | 62175013649 | 36000 CAPSULE, DELAYED RELEASE in 1 DRUM (62175-136-49) | 2009-01-23 | 0000-00-00 | No | No | Current |