Prescription drug · ANDA
esomeprazole magnesium NDC 70518-3850
Esomeprazole magnesium 40 mg/1 · Capsule, Delayed release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3850-0 | 70518385000 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0)Marketed from Sep 2, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 magnesium
- Generic name (nonproprietary)
- esomeprazole magnesium
- Active ingredients
- Esomeprazole magnesium — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213486
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-3850_53d62c6b-a17e-5bd5-e063-6394a90a2a50SPL ID 53d62c6b-a17e-5bd5-e063-6394a90a2a50SPL set ID e6e1906f-60be-402f-97f4-6d7bea1a6c08RxCUI 606730UNII R6DXU4WAY9
- 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
N470518385000followed by a unit qualifier and the quantityPackage 70518-3850-00. 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)
Esomeprazole is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213486
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 magnesium | Esomeprazole magnesium trihydrate 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8524 |
| esomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Biocon Pharma Inc., | 70377-055 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Biocon Pharma Inc., | 70377-056 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2476 |
| esomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3419 |
| esomeprazole magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9713 |
| esomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 82804-078 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-033 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-034 |