Omeprazole
- Product NDC
- 63187-787
- 11-digit product format
- 631870787
- Labeler code
- 63187
- Product ID
- 63187-787_83ca8d89-bbd6-4a72-aeb3-ac1b4f93cc88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- 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
- 2020-12-31
- 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 |
|---|
| 63187-787 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 3 | Legacy NDC | 20191115_1fdf446d-cd4e-491f-ac8b-c35c74fb2c91.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-787-30 | 63187078730 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-30) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-787-60 | 63187078760 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-60) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-787-72 | 63187078772 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-72) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-787-78 | 63187078778 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-78) | 2016-12-01 | 0000-00-00 | No | No | Current |
| 63187-787-90 | 63187078790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-90) | 2016-12-01 | 0000-00-00 | No | No | Current |