Prescription drug · ANDA
Pantoprazole Sodium (Pantoprazole) NDC 65162-637
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-637-03 | 6516206370365162063703 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-03)Marketed from Jun 20, 2016 | |
| 65162-637-09 | 6516206370965162063709 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09)Marketed from Jun 20, 2016 | |
| 65162-637-11 | 6516206371165162063711 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-11)Marketed from Jun 20, 2016 | |
| 65162-637-50 | 6516206375065162063750 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-50)Marketed from Jun 20, 2016 |
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
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205119
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-637_940df77d-5373-4196-946e-19271ac91087SPL ID 940df77d-5373-4196-946e-19271ac91087SPL set ID f3ded82a-cf0d-4844-944a-75f9f9215ff0RxCUI 251872, 314200UNII 6871619Q5XUPC 0365162637038
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465162063703followed by a unit qualifier and the quantityPackage 65162-0637-03. 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 delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). ( 1.1 ) Maintenance of Healing of Erosive Esophagitis. ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome. ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic reli…
Excerpt only. Read the full label for complete information.
About NDC 65162-637
- What is NDC 65162-637?
- 65162-637 is the product NDC for Pantoprazole Sodium (pantoprazole), Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pantoprazole Sodium (Pantoprazole).
- What is the active ingredient?
- Pantoprazole sodium.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 ANDA 205119
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 | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-837 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-974 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Amneal Pharmaceuticals LLC | 65162-636 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0291 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1636 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0085 |