esomeprazole magnesium
- Product NDC
- 70518-3850
- 11-digit product format
- 705183850
- Labeler code
- 70518
- Product ID
- 70518-3850_3f8bdbae-36f1-9e7a-e063-6294a90ac847
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213486
- Marketing category
- ANDA
- Marketing start
- 2023-09-02
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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 magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606730 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3850-0 | esomeprazole magnesium | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3850 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.] | 2 | Current NDC, 1 package rows | 20240403_e6e1906f-60be-402f-97f4-6d7bea1a6c08.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3850-0 | 70518385000 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0) | 2023-09-02 | No | No | Historical |