Esomeprazole magnesium
- Product NDC
- 70010-134
- 11-digit product format
- 700100134
- Labeler code
- 70010
- Product ID
- 70010-134_451b3f2a-df20-47e9-e063-6394a90a7068
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA217427
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- 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 | 606726, 606730 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-134-03 | Esomeprazole magnesium | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 4 |
| 70010-134-09 | Esomeprazole magnesium | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 4 |
| 70010-134-10 | Esomeprazole magnesium | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-134 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [GRANULES PHARMACEUTICALS INC.] | 3 | Current NDC, 3 package rows | 20231114_651cfdb1-d7c7-45e6-add0-f40eea7722f7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70010-134-03 | 70010013403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-134-03) | 2023-10-18 | No | No | Current |
| 70010-134-09 | 70010013409 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-134-09) | 2023-11-13 | No | No | Current |
| 70010-134-10 | 70010013410 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-134-10) | 2023-10-18 | No | No | Current |