Prescription drug · NDA
Pantoprazole Sodium NDC 0143-9284
Pantoprazole sodium 40 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9284-10 | 0014392841000143928410 | 10 VIAL in 1 CARTON (0143-9284-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9284-01)Marketed from Sep 22, 2017 |
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
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209463
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9284_284915b9-082e-4c76-8998-13aff7221045SPL ID 284915b9-082e-4c76-8998-13aff7221045SPL set ID b02f3f85-8f9b-4d06-8eae-73e592626f3eRxCUI 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
N400143928410followed by a unit qualifier and the quantityPackage 00143-9284-10. 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 for Injection 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 patien…
Excerpt only. Read the full label for complete information.
About NDC 0143-9284
- What is NDC 0143-9284?
- 0143-9284 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pantoprazole Sodium.
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
- 135 other product NDCs are listed under this name. See all Pantoprazole Sodium 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 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 | Pantoprazole sodium 40 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Avenacy, LLC | 83634-751 | 83634-0751-10 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-0289 | 55154-0289-00 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-727 | 50268-0727-10 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-066 | 87441-0066-01 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-065 | 87441-0065-01 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0347 | 67046-0347-03 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0536 | 67046-0536-03 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Safecor Health LLC | 48433-081 | 48433-0081-20 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NorthStar Rx LLC | 72603-746 | 72603-0746-0172603-0746-02 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/10mL | Injection, Powder, For solutionIntravenous | Devatis Inc. | 73043-020 | 73043-0020-0173043-0020-1073043-0020-25 |
Other NDCs under NDA 209463
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/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9300 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Cardinal Health 107, LLC | 55154-7477 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Civica, Inc. | 72572-553 |