Esomeprazole Magnesium
- Product NDC
- 0363-1699
- 11-digit product format
- 003631699
- Labeler code
- 0363
- Product ID
- 0363-1699_2425f611-2717-4486-aff3-82190c0b0d96
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- esomeprazole magnesium dihydrate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA207193
- Marketing category
- ANDA
- Marketing start
- 2020-03-22
- Substance
- ESOMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N3PA6559FT |
| Rxcui | 606726 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-1699-01 | Esomeprazole Magnesium | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 7 |
| 0363-1699-01 | Esomeprazole Magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 7 |
| 0363-1699-03 | Esomeprazole Magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 7 |
| 0363-1699-03 | Esomeprazole Magnesium | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-1699 | ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [WALGREEN COMPANY] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240802_29eb7b87-59a4-4d27-ad53-789da7fec427.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 |
|---|
| 0363-1699-01 | 00363169901 | 1 BOTTLE in 1 CARTON (0363-1699-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-03-22 | 0000-00-00 | No | No | Current |
| 0363-1699-03 | 00363169903 | 3 BOTTLE in 1 CARTON (0363-1699-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-03-26 | 0000-00-00 | No | No | Current |