Omeprazole
- Product NDC
- 70518-1261
- 11-digit product format
- 705181261
- Labeler code
- 70518
- Product ID
- 70518-1261_e3b0f501-baa5-fd39-e053-2a95a90aed98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076515
- Marketing category
- ANDA
- Marketing start
- 2018-06-18
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 |
|---|
| 70518-1261-3 | 70518126103 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-3) | 2020-09-08 | 0000-00-00 | No | No | Current |
| 70518-1261-4 | 70518126104 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-4) | 2020-12-23 | 0000-00-00 | No | No | Current |