Esomeprazole magnesium
- Product NDC
- 69097-507
- 11-digit product format
- 690970507
- Labeler code
- 69097
- Product ID
- 69097-507_75c5150c-7eab-4f85-9c34-80c0ecb4a07b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA217714
- Marketing category
- ANDA
- Marketing start
- 2025-01-07
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 36H71644EQ |
| Rxcui | 1297658, 1297761 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-507-31 | Esomeprazole magnesium | 30 in 1 CARTON | FOR SUSPENSION | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-507 | ESOMEPRAZOLE MAGNESIUM FOR SUSPENSION [CIPLA USA INC.] | 6 | Current NDC, 1 package rows | 20250108_e89589f1-945e-429a-819e-61755cba77fa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69097-507-31 | 69097050731 | 30 FOR SUSPENSION in 1 CARTON (69097-507-31) | 30 for suspension | 2025-01-07 | No | No | Current |