Omeprazole
- Product NDC
- 63629-2607
- Requested package NDC
- 63629-2607-0
- 11-digit product format
- 636292607
- Labeler code
- 63629
- Product ID
- 63629-2607_0a276c6b-0285-4e4d-9f2c-3cb73cabed77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075876
- Marketing category
- ANDA
- Marketing start
- 2003-08-04
- 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
- 2021-12-31
- 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 | 63629-2607 | 63629-2607-0 | 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 |
|---|---|---|---|---|---|---|---|
| A075876-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | ||
| A075876-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | ||
| A075876-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 |
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 | A075876-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A075876-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2003-05-29 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A075876-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | 2009-01-21 | a50c72e98297… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2607-0 | EA - Each | 63629-2607 | fd1035d1-34b4-47a2-ad30-6dd4e4d463cd | 1 | 2014-09-03 |
| 63629-2607-1 | EA - Each | 63629-2607 | b64e5625-4aa1-48a8-9219-e45642757f9b | 1 | 2012-07-24 |
| 63629-2607-2 | EA - Each | 63629-2607 | 8c7a58c1-09cf-4498-996a-74629ae00f98 | 1 | 2012-07-24 |
| 63629-2607-3 | EA - Each | 63629-2607 | e9ff3355-5409-4b9a-ab51-47d776272be1 | 1 | 2012-07-24 |
| 63629-2607-4 | EA - Each | 63629-2607 | ef8b8e52-16bf-41da-9543-4bff66143712 | 1 | 2012-07-24 |
| 63629-2607-5 | EA - Each | 63629-2607 | e44e185f-97cd-42a5-95f1-1b3674e3f8a9 | 1 | 2012-07-24 |
| 63629-2607-6 | EA - Each | 63629-2607 | a58ec682-db64-4078-8d95-8f3963eb41f5 | 1 | 2012-07-24 |
| 63629-2607-7 | EA - Each | 63629-2607 | f01ac394-a883-4863-b5b3-62e0fd264d0e | 1 | 2012-07-24 |
| 63629-2607-8 | EA - Each | 63629-2607 | 69cbc6c0-ea16-49b7-aedd-b36e08374ee9 | 1 | 2012-07-24 |
| 63629-2607-9 | EA - Each | 63629-2607 | 3df32df8-3035-43ac-b17f-17ac84510fa3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-2607-0 | 63629260700 | 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-0) | 2005-04-22 | 0000-00-00 | No | No | Current |