Omeprazole
- Product NDC
- 68071-2432
- 11-digit product format
- 680712432
- Labeler code
- 68071
- Product ID
- 68071-2432_eeb826c8-ccc6-c5bd-e053-2a95a90ab23f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 product | product | 68071-2432 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68071-2432 | 68071-2432-9 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | 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 | A091672-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091672-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091672-003 | 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 | 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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2432-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9e54-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2432 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC | 20221202_c3ca7ae0-46f9-2950-e053-2995a90aa6f8.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2432-9 | 68071243209 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2432-9) | 2021-06-02 | 0000-00-00 | No | No | Current |