Omeprazole
- Product NDC
- 70518-2295
- 11-digit product format
- 705182295
- Labeler code
- 70518
- Product ID
- 70518-2295_e6fcd6e1-1d13-60c0-e053-2995a90ac597
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-09-03
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2295 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.] | 13 | Legacy NDC | 20250311_50ba678e-98ee-44de-87d1-6dd6a1528c00.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2295-0 | 70518229500 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2295-0) | 2019-09-03 | 0000-00-00 | No | No | Current |
| 70518-2295-1 | 70518229501 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2295-1) | 2022-08-23 | 0000-00-00 | No | No | Current |