Prescription drug · ANDA
Esomeprazole Magnesium NDC 71335-2018
Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2018-1 | 71335201801 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1)Marketed from Feb 10, 2022 | |
| 71335-2018-2 | 71335201802 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2)Marketed from Feb 10, 2022 | |
| 71335-2018-3 | 71335201803 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3)Marketed from Feb 10, 2022 | |
| 71335-2018-4 | 71335201804 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4)Marketed from Feb 10, 2022 | |
| 71335-2018-5 | 71335201805 | 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5)Marketed from Feb 10, 2022 | |
| 71335-2018-6 | 71335201806 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6)Marketed from Feb 10, 2022 | |
| 71335-2018-7 | 71335201807 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7)Marketed from Feb 10, 2022 | |
| 71335-2018-8 | 71335201808 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8)Marketed from Feb 10, 2022 |
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 — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211977
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2018_d95a3df7-b940-4a73-8238-3608e58ca70bSPL ID d95a3df7-b940-4a73-8238-3608e58ca70bSPL set ID 7778bf7c-52f7-44b3-ac2c-e5a25f6967b7RxCUI 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
N471335201801followed by a unit qualifier and the quantityPackage 71335-2018-01. 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 capsule, 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 delayed-release capsules are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211977
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 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7896 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7360 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | American Health Packaging | 60687-934 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-4581 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-877 |
| Esomeprazole Magnesium DResomeprazole magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0331 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-665 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-664 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6198 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Direct Rx | 72189-318 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2040 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0419 |
| Esomeprazole DR | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-381 |
| Esomeprazole Magnesium | Esomeprazole magnesium 40 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-905 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0420 |
| Esomeprazole Magnesium | Esomeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-904 |