Prescription drug · ANDA
Pantoprazole Sodium NDC 25021-751
Pantoprazole sodium 40 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-751-10 | 25021075110 | 10 VIAL in 1 CARTON (25021-751-10) / 10 mL in 1 VIALMarketed from Jul 15, 2022 | |
| 25021-751-11 | 25021075111 | 25 VIAL in 1 CARTON (25021-751-11) / 10 mL in 1 VIALMarketed from Jul 15, 2022 |
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
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204400
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 25021-751_2b04a735-571c-4668-bc78-ac3a611d575cSPL ID 2b04a735-571c-4668-bc78-ac3a611d575cSPL set ID c39be14b-e881-4586-b77e-4747db494954RxCUI 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
N425021075110followed by a unit qualifier and the quantityPackage 25021-0751-10. 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 for 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 for injection as a treatment of patients with GERD and a …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204400
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/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-493 |
| Pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sun Pharmaceutical Industries Limited | 70095-024 |