Esomeprazole Sodium
- Product NDC
- 55150-185
- 11-digit product format
- 551500185
- Labeler code
- 55150
- Product ID
- 55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA204657
- Marketing category
- ANDA
- Marketing start
- 2016-08-10
- Substance
- ESOMEPRAZOLE SODIUM
- 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 Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE SODIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L2C9GWQ43H |
| Rxcui | 486501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-185-05 | Esomeprazole Sodium | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 12 |
| 55150-185-05 | Esomeprazole Sodium | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-185 | ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240829_45a15ba2-2aae-4edc-beaa-4a2357d87f32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-185-05 | 55150018505 | 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 10 vial | 2016-08-10 | 0000-00-00 | No | No | Current |