Prescription drug · ANDA
Pantoprazole Sodium DR (pantoprazole sodium) NDC 80425-0162
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0162-1 | 80425016201 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-1)Marketed from Sep 10, 2014 | |
| 80425-0162-2 | 80425016202 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-2)Marketed from Sep 10, 2014 | |
| 80425-0162-3 | 80425016203 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-3)Marketed from Sep 10, 2014 |
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)
- Pantoprazole Sodium DRSuffix: DR
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202882
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0162_2a99a670-af2e-299d-e063-6294a90a05d2SPL ID 2a99a670-af2e-299d-e063-6294a90a05d2SPL set ID c89a5396-1d94-c7fa-e053-2995a90a9063RxCUI 314200UNII 6871619Q5X
- 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
N480425016201followed by a unit qualifier and the quantityPackage 80425-0162-01. 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)
1. Indications and Usage Section INDICATIONS AND USAGE Pantoprazole Sodium Delayed-Release Tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202882
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 |
|---|---|---|---|---|
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2215 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-654 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-679 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-112 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-671 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-674 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2285 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0278 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0551 |
| Pantoprazole Sodium DR | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Direct_Rx | 72189-514 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-727 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1572 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8644 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-653 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-659 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4864 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-668 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-669 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-744 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-831 |
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