NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Product NDC
- 70748-215
- 11-digit product format
- 707480215
- Labeler code
- 70748
- Product ID
- 70748-215_299bc1f9-3164-4413-8c94-a972b1d98463
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- NDA022511
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-03-04
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Active strength
- 20 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70748-215-07 | 70748021507 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-215-07) | 2020-03-04 | 0000-00-00 | No | No | Current |