Esomeprazole
- Product NDC
- 0591-4187
- 11-digit product format
- 005914187
- Labeler code
- 0591
- Product ID
- 0591-4187_317e8c26-a7c9-4330-bdf2-bd7d952df5b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA209202
- Marketing category
- ANDA
- Marketing start
- 2019-10-30
- Marketing end
- 2021-12-31
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- Active strength
- 20 mg/1
- 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 |
|---|
| 0591-4187-14 | 00591418714 | 14 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-14) | 2019-10-30 | 2021-12-31 | No | No | Current |
| 0591-4187-42 | 00591418742 | 42 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-42) | 2019-10-30 | 2021-12-31 | No | No | Current |
| 0591-4187-96 | 00591418796 | 28 TABLET, DELAYED RELEASE in 1 CARTON (0591-4187-96) | 2019-10-30 | 2021-12-31 | No | No | Current |