Esomeprazole sodium
- Product NDC
- 70436-190
- 11-digit product format
- 704360190
- Labeler code
- 70436
- Product ID
- 70436-190_ee346f3b-2e1c-7302-e053-2995a90a7157
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA215732
- Marketing category
- ANDA
- Marketing start
- 2022-02-25
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE SODIUM
- Active strength
- 40 mg/5mL
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-190-80 | Esomeprazole sodium | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 3 |
| 70436-190-82 | Esomeprazole sodium | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-190 | ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] | 3 | Legacy NDC, 2 package rows | 20231026_23395673-116d-4a8e-b0ce-59f9ca5b3daf.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 |
|---|
| 70436-190-80 | 70436019080 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 70436-190-82 | 70436019082 | 10 VIAL in 1 CARTON (70436-190-82) > 5 mL in 1 VIAL (70436-190-80) | 10 vial | 2022-02-25 | 0000-00-00 | No | No | Current |