Prescription drug · NDA
Protonix I.V. (Pantoprazole sodium) NDC 0008-0923
Pantoprazole sodium 40 mg/10mL · Injection, Powder, For solution · Intravenous · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0008-0923-51 | 0000809235100008092351 | 1 VIAL in 1 CARTON (0008-0923-51) / 10 mL in 1 VIALMarketed from May 1, 2001 | |
| 0008-0923-55 | 0000809235500008092355 | 10 CARTON in 1 PACKAGE (0008-0923-55) / 1 VIAL in 1 CARTON / 10 mL in 1 VIALMarketed from May 1, 2001 | |
| 0008-0923-60 | 0000809236000008092360 | 25 CARTON in 1 PACKAGE (0008-0923-60) / 1 VIAL in 1 CARTON / 10 mL in 1 VIALMarketed from May 1, 2001 |
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)
- 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
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDC labeler code 0008
- 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 0008-0923_a7e7d657-a748-4234-8dd6-c0e4d0f81a86SPL ID a7e7d657-a748-4234-8dd6-c0e4d0f81a86SPL set ID 51e4144a-489e-436c-609a-39305f8f56baRxCUI 283669, 885257UNII 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
N400008092351followed by a unit qualifier and the quantityPackage 00008-0923-51. 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.
About NDC 0008-0923
- What is NDC 0008-0923?
- 0008-0923 is the product NDC for Protonix I.V. (pantoprazole sodium), Pantoprazole sodium 40 mg/10mL injection, powder, for solution, listed with the FDA by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Protonix I.V. (Pantoprazole sodium).
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., NDC labeler code 0008. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Protonix I.V.?
- 3 other product NDCs are listed under this name. See all Protonix 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 Protonix 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) |
|---|---|---|---|---|---|
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4001 | 00008-4001-1000008-4001-25 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Cardinal Health 107, LLC | 55154-4225 | 55154-4225-05 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Cardinal Health 107, LLC | 55154-4236 | 55154-4236-05 |
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 | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-4001 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Cardinal Health 107, LLC | 55154-4225 |
| Protonix I.V.pantoprazole sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Cardinal Health 107, LLC | 55154-4236 |