Prescription drug · ANDA
Pantoprazole Sodium I.V. (Pantoprazole sodium) NDC 66794-258
Pantoprazole sodium 40 mg/10mL · Injection, Powder, For solution · Intravenous · Piramal Critical Care
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-258-41 | 6679402584166794025841 | 1 VIAL in 1 CARTON (66794-258-41) / 10 mL in 1 VIALMarketed from Oct 10, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 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
- Piramal Critical CareNDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214680
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 66794-258_390349ed-4093-e0b3-e063-6294a90a474eSPL ID 390349ed-4093-e0b3-e063-6294a90a474eSPL set ID 0696b10c-972b-9dcf-e063-6294a90a1034RxCUI 283669UNII 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
N466794025841followed by a unit qualifier and the quantityPackage 66794-0258-41. 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 for injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.’s PROTONIX ® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole…
Excerpt only. Read the full label for complete information.
About NDC 66794-258
- What is NDC 66794-258?
- 66794-258 is the product NDC for Pantoprazole Sodium I.V. (pantoprazole sodium), Pantoprazole sodium 40 mg/10mL injection, powder, for solution, listed with the FDA by Piramal Critical Care. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pantoprazole Sodium I.V. (Pantoprazole sodium).
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Piramal Critical Care, NDC labeler code 66794. 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 I.V.?
- 1 other product NDC are listed under this name. See all Pantoprazole Sodium I.V. 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 I.V. 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 I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Sandoz Inc | 0781-3480 | 00781-3480-95 |