Prescription drug · NDA
Pantoprazole Sodium NDC 0338-9646
pantoprazole sodium in 0.9% sodium chloride · Pantoprazole sodium 40 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9646-24 | 00338964624 | 24 BAG in 1 CARTON (0338-9646-24) / 50 mL in 1 BAG (0338-9646-01)Marketed from Feb 14, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 in 0.9% sodium chloride
- Active ingredients
- Pantoprazole sodium — 40 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217512
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0338-9646_38f70f97-5429-45e4-ad5f-da4c1e2c6233SPL ID 38f70f97-5429-45e4-ad5f-da4c1e2c6233SPL set ID a476e063-9450-4793-9a22-16b0a0a61cd0RxCUI 2675781, 2675784, 2675786UNII 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 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
N400338964624followed by a unit qualifier and the quantityPackage 00338-9646-24. 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 is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 217512
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 sodium in 0.9% sodium chloride | Pantoprazole sodium 80 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-9648 |
| Pantoprazole Sodiumpantoprazole sodium in 0.9% sodium chloride | Pantoprazole sodium 40 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-9644 |