Prescription drug · ANDA
Naproxen and esomeprazole magnesium NDC 50228-438
Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-438-05 | 5022804380550228043805 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05)Marketed from Oct 11, 2023 | |
| 50228-438-30 | 5022804383050228043830 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-30)Marketed from Oct 11, 2023 | |
| 50228-438-60 | 5022804386050228043860 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-60)Marketed from Mar 12, 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 — 500 mg/1Esomeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, IncNDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217738
- 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 50228-438_2faf3061-f567-a5dc-e063-6294a90aff8bSPL ID 2faf3061-f567-a5dc-e063-6294a90aff8bSPL set ID 167340c2-1234-4d00-b4e2-cccf3d270fdaRxCUI 994005, 994008UNII 57Y76R9ATQ, R6DXU4WAY9UPC 0350228437103, 0350228438605, 0350228438056, 0350228437301, 0350228437608, 0350228438308
- 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
N450228043805followed by a unit qualifier and the quantityPackage 50228-0438-05. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets are indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomepraz…
Excerpt only. Read the full label for complete information.
About NDC 50228-438
- What is NDC 50228-438?
- 50228-438 is the product NDC for Naproxen and esomeprazole magnesium, Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen and esomeprazole magnesium.
- What is the active ingredient?
- Naproxen, Esomeprazole magnesium.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc, NDC labeler code 50228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen and esomeprazole magnesium?
- 20 other product NDCs are listed under this name. See all Naproxen and esomeprazole magnesium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen and esomeprazole magnesium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4166 | 68788-4166-0368788-4166-06 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4043 | 68788-4043-0368788-4043-06 |
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc | 68788-8906 | 68788-8906-0368788-8906-06 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8766 | 68788-8766-0368788-8766-06 |
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | ScieGen Pharmaceuticals, Inc | 50228-437 | 50228-0437-1050228-0437-3050228-0437-60 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2552 | 71335-2552-0171335-2552-02 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 82804-303 | 82804-0303-60 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1438 | 85509-1438-0185509-1438-0385509-1438-06+1 more |
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Ajanta Pharma USA Inc. | 27241-202 | 27241-0202-60 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Ajanta Pharma USA Inc. | 27241-203 | 27241-0203-60 |
Other NDCs under ANDA 217738
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 375 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | ScieGen Pharmaceuticals, Inc | 50228-437 |
| Naproxen and esomeprazole magnesium | Naproxen 375 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc | 68788-8906 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2552 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium trihydrate 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 82804-303 |
| Naproxen and esomeprazole magnesium | Naproxen 500 mg/1; Esomeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1438 |