Omeprazole
- Product NDC
- 70518-1209
- 11-digit product format
- 705181209
- Labeler code
- 70518
- Product ID
- 70518-1209_909db93b-9a9c-4f99-e053-2995a90ade26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2018-05-16
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 product | product | 70518-1209 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70518-1209 | 70518-1209-0 | 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 |
|---|---|---|---|---|---|---|---|
| A075576-001 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | |
| A075576-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A075576-003 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075576-001 | AB |
| A075576-002 | AB |
| A075576-003 | 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 | A075576-001 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075576-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075576-003 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 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 | A075576-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075576-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075576-003 | 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 | St. Mary's Medical Park Pharmacy | 1eb57c13-25ed-70bc-e063-6294a90afdac | 2026-06-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | aae3bf9f-5d05-889f-e053-2995a90a5ff2 | 2025-12-26 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | QPharma, Inc. | f5dcf0b2-4fa2-023a-e053-2995a90a183a | 2025-12-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quallent Pharmaceuticals Health LLC | 665e9877-85ac-fdb6-54ac-1c47941ceab8 | 2025-11-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | e235ef89-3592-4ca1-8c13-d7ce84b1001c | 2025-10-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | American Health Packaging | a17e415e-a559-4a8d-a455-699184a01523 | 2025-02-17 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85e324-ef9f-196c-e053-2995a90a384e | 2024-12-31 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Quality Care Products, LLC | 581d1c3d-457a-41f2-8db0-5b6219cdcb09 | 2024-12-16 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | f0f61a89-700d-481d-9255-6f9a9afa7025 | 2024-10-01 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | 1d4ecc1e-5180-f75e-e063-6394a90a51a6 | 2024-07-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | e1f20429-cfaa-420b-a65a-271be37eb799 | 2024-05-28 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | Dr. Reddy's Laboratories Limited | 72fb11b6-b08c-2f02-d82b-f60f52394903 | 2024-04-15 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68 | 2023-09-10 | Warnings, Adverse reactions | 075576 ANDA075576 |
| Omeprazole | OMEPRAZOLE | NorthStar Rx LLC | c5af5f4b-17be-7245-b281-f27c87831242 | 2023-06-20 | Warnings, Adverse reactions | 075576 ANDA075576 |