Prescription drug · NDA
Esomeprazole Strontium NDC 70849-400
Esomeprazole strontium 40 mg/1 · Capsule, Delayed release · Oral · R2 Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70849-400-30 | 70849040030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-400-30)Marketed from Sep 15, 2016 |
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)
- Esomeprazole Strontium
- Generic name (nonproprietary)
- esomeprazole strontium
- Active ingredients
- Esomeprazole strontium — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- R2 Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202342
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70849-400_3d19523d-7cb5-2f2f-e054-00144ff88e88SPL ID 3d19523d-7cb5-2f2f-e054-00144ff88e88SPL set ID 3c916d32-f9e9-1d15-e054-00144ff88e88RxCUI 1810787, 1810789UNII C5N25H3803UPC 0370849400300, 0370849200306
- Pharmacologic class
- 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
N470849040030followed by a unit qualifier and the quantityPackage 70849-0400-30. 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 .
Indications (excerpt from the label)
1.INDICATIONS & USAGE SECTION 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomepraz…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202342
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 |
|---|---|---|---|---|
| Esomeprazole Strontium | Esomeprazole strontium 20 mg/1 | Capsule, Delayed releaseOral | R2 Pharma, LLC | 70849-200 |