Prescription drug · ANDA
Esomeprazole magnesium NDC 76420-227
esomeprazole magnesium delayed release capsules · Esomeprazole magnesium 40 mg/1 · Capsule, Coated pellets · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-227-30 | 76420022730 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30)Marketed from Jul 27, 2022 | |
| 76420-227-60 | 76420022760 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60)Marketed from Jul 27, 2022 | |
| 76420-227-90 | 76420022790 | 90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)Marketed from Jul 27, 2022 |
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 magnesium
- Generic name (nonproprietary)
- esomeprazole magnesium delayed release capsules
- Active ingredients
- Esomeprazole magnesium — 40 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210559
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565SPL ID 23b36bd4-0dbd-366a-e063-6294a90a1565SPL set ID 85a963c1-9c13-4eb7-826b-08d5a991fe28RxCUI 606726, 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
N476420022730followed by a unit qualifier and the quantityPackage 76420-0227-30. 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)
Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD) ( 1.1 ) Risk reduction of NSAID-associated gastric ulcer ( 1.2 ) H. pylori eradication to reduce the risk of duodenal ulcer recurrence ( 1.3 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome ( 1.4 ) 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium 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 w…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210559
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 magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 20 mg/1 | Capsule, Coated pelletsOral | Asclemed USA, Inc. | 76420-226 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium trihydrate 20 mg/1 | Capsule, Coated pelletsOral | Proficient Rx LP | 71205-706 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 20 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-571 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 40 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-572 |
| Esomeprazole magnesiumesomeprazole magnesium delayed release capsules | Esomeprazole magnesium 20 mg/1 | Capsule, Coated pelletsOral | Bryant Ranch Prepack | 71335-9678 |