ESOMEPRAZOLE STRONTIUM
- Product NDC
- 70849-400
- 11-digit product format
- 708490400
- Labeler code
- 70849
- Product ID
- 70849-400_3d19523d-7cb5-2f2f-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole strontium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- R2 Pharma, LLC
- Application
- NDA202342
- Marketing category
- NDA
- Marketing start
- 2016-09-15
- Substance
- ESOMEPRAZOLE STRONTIUM
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESOMEPRAZOLE STRONTIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE STRONTIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C5N25H3803 |
| Rxcui | 1810787, 1810789 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70849-400-30 | ESOMEPRAZOLE STRONTIUM | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70849-400 | ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [R2 PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20161102_3c916d32-f9e9-1d15-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70849-400-30 | 70849040030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-400-30) | 2016-09-15 | 0000-00-00 | No | No | Current |