leader esomeprazole magnesium
- Product NDC
- 70000-0727
- 11-digit product format
- 700000727
- Labeler code
- 70000
- Product ID
- 70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA207193
- Marketing category
- ANDA
- Marketing start
- 2025-04-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| N3PA6559FT | ESOMEPRAZOLE | 119141-88-7 | ESOMEPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70000-0727-1 | 70000072701 | 3 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2025-04-23 | No | No | Historical |
| 70000-0727-2 | 70000072702 | 1 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2025-04-02 | No | No | Historical |