Naproxen and Esomeprazole Magnesium
- Product NDC
- 0378-4385
- 11-digit product format
- 003784385
- Labeler code
- 0378
- Product ID
- 0378-4385_34e7c117-7512-442e-bd87-059b09180509
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naproxen and esomeprazole magnesium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204920
- Marketing category
- ANDA
- Marketing start
- 2021-11-22
- 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 |
|---|
| 0378-4385-91 | 00378438591 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4385-91) | 2021-11-22 | 0000-00-00 | No | No | Current |