Esomeprazole magnesium
- Product NDC
- 71335-2449
- 11-digit product format
- 713352449
- Labeler code
- 71335
- Product ID
- 71335-2449_f1d20353-c0e3-4ae0-9f8f-01cc6e9fa5a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217427
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606730 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2449-1 | 71335244901 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-1) | 2024-08-15 | No | No | Historical |
| 71335-2449-2 | 71335244902 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-2) | 2024-08-15 | No | No | Historical |
| 71335-2449-3 | 71335244903 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-3) | 2024-08-15 | No | No | Historical |
| 71335-2449-4 | 71335244904 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-4) | 2024-08-15 | No | No | Historical |
| 71335-2449-5 | 71335244905 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-5) | 2024-08-15 | No | No | Historical |
| 71335-2449-6 | 71335244906 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-6) | 2024-08-15 | No | No | Historical |
| 71335-2449-7 | 71335244907 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-7) | 2024-08-15 | No | No | Historical |