Omeprazole
- Product NDC
- 63629-8108
- 11-digit product format
- 636298108
- Labeler code
- 63629
- Product ID
- 63629-8108_19802b01-27f7-426e-9587-f8319f8f1f8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8108-1 | 63629810801 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8108-1) | 2019-08-21 | 0000-00-00 | No | No | Current |
| 63629-8108-2 | 63629810802 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8108-2) | 2019-07-19 | 0000-00-00 | No | No | Current |