Naproxen and esomeprazole magnesium
- Product NDC
- 82804-276
- 11-digit product format
- 828040276
- Labeler code
- 82804
- Product ID
- 82804-276_5fd008ef-8388-48e9-8d38-76e0106bd5b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen and esomeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA213699
- Marketing category
- ANDA
- Marketing start
- 2022-10-06
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAPROXEN
- Active strength
- 20; 500 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen and esomeprazole magnesium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | 20 mg/1 |
| NAPROXEN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9, 57Y76R9ATQ |
| Rxcui | 994008 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-276-60 | Naproxen and esomeprazole magnesium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-276-60 | 82804027660 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (82804-276-60) | 2026-03-31 | No | No | Current |