Prescription drug · ANDA
Pantoprazole Sodium NDC 85534-0061
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0061-0 | 85534006100 | 10 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-0)Marketed from Jun 26, 2026 | |
| 85534-0061-1 | 85534006101 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-1)Marketed from Jun 26, 2026 | |
| 85534-0061-2 | 85534006102 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-2)Marketed from Jun 26, 2026 | |
| 85534-0061-3 | 85534006103 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-3)Marketed from Jun 26, 2026 | |
| 85534-0061-4 | 85534006104 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-4)Marketed from Jun 26, 2026 | |
| 85534-0061-5 | 85534006105 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0061-5)Marketed from Jun 26, 2026 |
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
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202038
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 85534-0061_5522a929-a1b7-d0e4-e063-6394a90ae106SPL ID 5522a929-a1b7-d0e4-e063-6394a90ae106SPL set ID f403c94d-68b7-43df-8c8e-c9fef3309cfcRxCUI 251872, 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
N485534006100followed by a unit qualifier and the quantityPackage 85534-0061-00. 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)
Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium 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). Fo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202038
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 Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | QPharma Inc | 42708-185 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5361 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5378 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-7458 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5379 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0347 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-0860 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-4165 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0536 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-065 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-066 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8113 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-1298 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-6870 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1165 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-075 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-805 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-806 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4895 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-725 |
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