Esomeprazole Magnesium
- Product NDC
- 68382-849
- 11-digit product format
- 683820849
- Labeler code
- 68382
- Product ID
- 68382-849_bc31956a-671b-4ca3-b9dd-1fdb03003cae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206055
- Marketing category
- ANDA
- Marketing start
- 2023-06-30
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- 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 DIHYDRATE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 36H71644EQ |
| Rxcui | 692576, 692578 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-849-94 | Esomeprazole Magnesium | 30 in 1 CARTON | GRANULE, DELAYED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-849 | ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 2 | Current NDC, 1 package rows | 20230819_190a4c5b-1547-45d7-b00b-10da4131e2e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-849-94 | 68382084994 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94) | 2023-06-30 | No | No | Historical |