OMEPRAZOLE
- Product NDC
- 51991-643
- 11-digit product format
- 519910643
- Labeler code
- 51991
- Product ID
- 51991-643_c3c3d3a2-cdfd-459c-be95-222601fdc33c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEPRAZOLE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA203481
- Marketing category
- ANDA
- Marketing start
- 2017-07-03
- Marketing end
- 2022-02-28
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-643-10 | 51991064310 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-643-10) | 2017-07-03 | 2022-02-28 | No | No | Current |