Prescription drug · ANDA
Pantoprazole Sodium DR (Pantoprazole sodium) NDC 80425-0278
Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0278-1 | 8042502780180425027801 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-1)Marketed from Mar 30, 2023 | |
| 80425-0278-2 | 8042502780280425027802 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-2)Marketed from Feb 28, 2023 | |
| 80425-0278-3 | 8042502780380425027803 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-3)Marketed from Feb 28, 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)
- Pantoprazole Sodium DRSuffix: DR
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0278_2a9bf621-afb8-7627-e063-6294a90a77a9SPL ID 2a9bf621-afb8-7627-e063-6294a90a77a9SPL set ID f5c9e3c6-d4b0-0ebe-e053-2995a90abe55RxCUI 251872UNII 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
N480425027801followed by a unit qualifier and the quantityPackage 80425-0278-01. 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 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. 1.2 Maintenance of Healing of …
Excerpt only. Read the full label for complete information.
About NDC 80425-0278
- What is NDC 80425-0278?
- 80425-0278 is the product NDC for Pantoprazole Sodium DR (pantoprazole sodium), Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pantoprazole Sodium DR (Pantoprazole Sodium).
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pantoprazole Sodium DR?
- 6 other product NDCs are listed under this name. See all Pantoprazole Sodium DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pantoprazole Sodium DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0406 | 80425-0406-0180425-0406-0280425-0406-03 |
| Pantoprazole Sodium DR | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Direct_Rx | 72189-514 | 72189-0514-3072189-0514-90 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0085 | 80425-0085-03 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0133 | 80425-0133-0180425-0133-0280425-0133-03 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0162 | 80425-0162-0180425-0162-0280425-0162-03 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0179 | 80425-0179-0280425-0179-03 |
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 20 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-744 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-727 |
| 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 | Proficient Rx LP | 63187-831 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0551 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5794 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5793 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1572 |
| 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 | 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 | HAWAII REPACK, INC. | 85534-0028 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0133 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | HAWAII REPACK, INC. | 85534-0062 |
| 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 | XLCare Pharmaceuticals Inc. | 72865-229 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | XLCare Pharmaceuticals Inc. | 72865-230 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0162 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-010 |
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