Prescription drug · NDA
Protonix I.V. (pantoprazole sodium) NDC 55154-4225
Pantoprazole sodium 40 mg/10mL · Injection, Powder, For solution · Intravenous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4225-5 | 55154422505 | 5 VIAL in 1 BAG (55154-4225-5) / 10 mL in 1 VIALMarketed from May 1, 2001 |
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)
- Protonix I.V.Suffix: I.V.
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/10mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020988
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-4225_6cf320ab-12a1-4a53-b3ac-2d1a803bdcb0SPL ID 6cf320ab-12a1-4a53-b3ac-2d1a803bdcb0SPL set ID 3cde88e6-28f2-4cbe-8c3f-770b05cc0e1bRxCUI 283669, 885257UNII 6871619Q5XUPC 0055154422550
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455154422505followed by a unit qualifier and the quantityPackage 55154-4225-05. 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)
PROTONIX I.V. is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older. • pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. PROTONIX I.V. is a proton pump inhibitor (PPI) indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020988
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 |
|---|---|---|---|---|
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Cardinal Health 107, LLC | 55154-4236 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4001 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923 |