esomeprazole magnesium
- Product NDC
- 71335-9713
- 11-digit product format
- 713359713
- Labeler code
- 71335
- Product ID
- 71335-9713_9a404143-c284-41e8-a20b-f399a87f658e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213486
- Marketing category
- ANDA
- Marketing start
- 2021-03-19
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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 |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9713-1 | 71335971301 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-1) | 2023-05-25 | No | No | Historical |
| 71335-9713-2 | 71335971302 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-2) | 2023-05-25 | No | No | Historical |
| 71335-9713-3 | 71335971303 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-3) | 2023-05-25 | No | No | Historical |
| 71335-9713-4 | 71335971304 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-4) | 2023-05-25 | No | No | Historical |
| 71335-9713-5 | 71335971305 | 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-5) | 2023-05-25 | No | No | Historical |
| 71335-9713-6 | 71335971306 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-6) | 2023-05-25 | No | No | Historical |
| 71335-9713-7 | 71335971307 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-7) | 2023-05-25 | No | No | Historical |
| 71335-9713-8 | 71335971308 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9713-8) | 2023-05-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| esomeprazole magnesium | Bryant Ranch Prepack | 2024-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 102 |