Prescription drug · ANDA
Naproxen and esomeprazole magnesium NDC 76420-890
Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-890-01 | 76420089001 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-01)Marketed from Dec 28, 2024 | |
| 76420-890-30 | 76420089030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-30)Marketed from Dec 28, 2024 | |
| 76420-890-60 | 76420089060 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-60)Marketed from Dec 28, 2024 | |
| 76420-890-90 | 76420089090 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-890-90)Marketed from Dec 28, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Naproxen and esomeprazole magnesium
- Generic name (nonproprietary)
- naproxen and esomeprazole magnesium
- Active ingredients
- Naproxen — 375 mg/1Esomeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204206
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-890_2a4fb535-ba1a-05d6-e063-6394a90a0b29SPL ID 2a4fb535-ba1a-05d6-e063-6394a90a0b29SPL set ID 7b3af5a8-0c92-43f4-af13-7a47dca20e92RxCUI 994005, 994008UNII R6DXU4WAY9, 57Y76R9ATQ
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Proton Pump Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420089001followed by a unit qualifier and the quantityPackage 76420-0890-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 204206
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4043 |
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-289 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2553 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-889 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-701 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Doc Rx | 69306-005 |