Omeprazole
- Product NDC
- 55700-410
- 11-digit product format
- 557000410
- Labeler code
- 55700
- Product ID
- 55700-410_3bb8268b-a4b4-4672-ab9d-3452afebe6b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2014-03-01
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-410 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC] | 8 | Legacy NDC | 20241219_1aafe2e2-4c0d-4784-b757-b526e57c1468.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-410-30 | 55700041030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-410-30) | 2016-05-12 | 0000-00-00 | No | No | Current |
| 55700-410-60 | 55700041060 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-410-60) | 2016-05-12 | 0000-00-00 | No | No | Current |