Omeprazole
- Product NDC
- 67544-510
- Requested package NDC
- 67544-510-53
- 11-digit product format
- 675440510
- Labeler code
- 67544
- Product ID
- 67544-510_4180c451-9b68-48f2-857b-53f7efe79a9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2002-11-04
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 67544-510 | 67544-510-53 | D | Discontinued by firm | 2026-07-31 |
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 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67544-510-30 | EA - Each | 67544-510 | b3b6eb78-430e-410d-9182-3d946a9f6755 | 1 | 2013-02-13 |
| 67544-510-53 | EA - Each | 67544-510 | 2e36deb0-0a67-495e-b1ec-65c947b11393 | 1 | 2013-02-13 |
| 67544-510-60 | EA - Each | 67544-510 | eb7f32dc-c8ac-4d69-996d-0a61aaf5745b | 1 | 2013-02-13 |
| 67544-510-70 | EA - Each | 67544-510 | 773d762d-3272-4f54-9eb2-d34ac4834440 | 1 | 2013-02-13 |
| 67544-510-80 | EA - Each | 67544-510 | 2e55d421-52fe-49ce-82a8-feb4fa26e834 | 1 | 2013-02-13 |
| 67544-510-94 | EA - Each | 67544-510 | fe492271-477c-4c61-a647-d2784c322bb8 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67544-510-53 | 67544051053 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67544-510-53) | 2006-03-07 | 0000-00-00 | No | No | Current |