Prescription drug · ANDA
Esomeprazole Magnesium NDC 45865-163
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Medsource Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45865-163-30 | 45865016330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30)Marketed from Jul 28, 2022 | |
| 45865-163-60 | 45865016360 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)Marketed from Dec 28, 2020 |
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
- Active ingredients
- Esomeprazole magnesium — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Medsource Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078279
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73SPL ID 1278c4e8-89c4-94b5-e063-6294a90a7d73SPL set ID 1278cf6f-cc7a-462b-e063-6394a90a34e5RxCUI 606726UNII 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
N445865016330followed by a unit qualifier and the quantityPackage 45865-0163-30. 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 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 eradicatio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078279
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 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8511 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc | 43598-510 |
| Esomeprazole Magnesium | Esomeprazole magnesium trihydrate 40 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6581 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc | 43598-509 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3934 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-143 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-391 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-979 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-980 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3735 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5134 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6943 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | AvPAK | 50268-272 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-964 |