Omeprazole 20 mg
- Product NDC
- 25000-094
- Requested package NDC
- 25000-094-76
- 11-digit product format
- 250000094
- Labeler code
- 25000
- Product ID
- 25000-094_a18acd7b-add6-4935-a0dd-7b2a27d817ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole 20 mg
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA218829
- Marketing category
- ANDA
- Marketing start
- 2026-08-05
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218829-001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218829-001 | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2025-08-07 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole 20 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 426QFE7XLK | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omeprazole 20 mg | OMEPRAZOLE 20 MG | MARKSANS PHARMA LIMITED | 5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c | 2026-08-05 | Warnings | 218829 ANDA218829 25000-094-76 25000-094 25000009476 |
| Omeprazole Delayed-Release | OMEPRAZOLE | H-E-B | 448ba584-6a6e-3d85-e063-6294a90a5579 | 2026-04-29 | Warnings | 218829 ANDA218829 |
| 24 HOUR Omeprazole | OMEPRAZOLE 20 MG | Grocery Outlet, Inc. | 4466f17c-c27b-8393-e063-6394a90a803d | 2026-03-23 | Warnings | 218829 ANDA218829 |
| Omeprazole delayed release | OMEPRAZOLE 20MG | TIME CAP LABORATORIES, INC. | 40906798-cd84-fbd0-e063-6294a90a1d29 | 2025-11-22 | Warnings | 218829 ANDA218829 |
| Omeprazole 20 mg | OMEPRAZOLE 20 MG | MARKSANS PHARMA LIMITED | 921bf750-9dd7-42ff-82bb-043b03f0fe69 | 2025-08-11 | Warnings | 218829 ANDA218829 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Status |
|---|---|---|---|---|---|---|
| 25000-094-76 | 25000009476 | 1 BOTTLE in 1 CARTON (25000-094-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2026-08-05 | 0 | Current |