Prescription drug · ANDA
Pantoprazole Sodium NDC 55154-4346
Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4346-0 | 55154434600 | 10 BLISTER PACK in 1 BAG (55154-4346-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jan 28, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078281
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-4346_0e08a205-45c7-4ce8-8482-ef4b3134a9c6SPL ID 0e08a205-45c7-4ce8-8482-ef4b3134a9c6SPL set ID 410d5577-e50a-44f3-aaa8-fbf391a0c261RxCUI 251872UNII 6871619Q5XUPC 0055154434607
- 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
N455154434600followed by a unit qualifier and the quantityPackage 55154-4346-00. 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, USP are indicated for: Pantoprazole 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 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).…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078281
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 | Lannett Company, Inc. | 62175-617 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Lannett Company, Inc. | 62175-618 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-938 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-1746 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-612 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-613 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Chartwell RX, LLC | 62135-533 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-027 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Chartwell RX, LLC | 62135-534 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-585 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-639 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-086 |