Omeprazole
- Product NDC
- 0615-7933
- 11-digit product format
- 006157933
- Labeler code
- 0615
- Product ID
- 0615-7933_64d49120-dfc4-4237-95b2-518b7d36b52f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2003-01-28
- Marketing end
- 2020-12-31
- 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
- 0000-00-00
- 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 | 0615-7933 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0615-7933 | 0615-7933-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-7933 | 0615-7933-14 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-7933 | 0615-7933-31 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-7933 | 0615-7933-39 | 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 |
|---|---|---|---|---|---|---|---|
| A075757-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | |
| A075757-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075757-001 | AB |
| A075757-002 | 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 | A075757-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075757-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2003-01-28 | 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 | A075757-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075757-002 | 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 | db9f071b-85f4-061f-e053-2995a90a3ff5 | 2026-06-26 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | QPharma Inc | f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf | 2026-05-11 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | f76c23d5-26b6-cfb2-e053-6294a90aea42 | 2026-01-01 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | 0fb314cb-6291-422c-98ff-24d8449992f6 | 2025-04-23 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Chartwell RX, LLC | 4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e | 2025-02-12 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Sandoz Inc | 516170d4-4913-4577-a2d2-f5c52d1e79c6 | 2024-12-31 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | ee0598a1-0e5e-40ff-ad88-b0adfc533ca0 | 2024-12-01 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 17664f71-154a-47c6-b83c-b349bbc8a98f | 2024-08-08 | Warnings, Adverse reactions | 075757 ANDA075757 |
| Omeprazole | OMEPRAZOLE | Sandoz Inc | e4562da8-9d94-4417-9f80-c1ffd4247259 | 2023-04-30 | Warnings, Adverse reactions | 075757 ANDA075757 |