Prescription drug · ANDA
Pantoprazole Sodium NDC 50090-5378
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5378-0 | 5009053780050090537800 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5378-0)Marketed from Nov 19, 2020 | |
| 50090-5378-1 | 5009053780150090537801 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5378-1)Marketed from Nov 19, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Tablet, Delayed release
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202038
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5378_3eab803f-6666-43bc-a22b-bbade6c881e3SPL ID 3eab803f-6666-43bc-a22b-bbade6c881e3SPL set ID f1eb666a-120d-47fd-8c9f-73cef839294aRxCUI 314200UNII 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 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
N450090537800followed by a unit qualifier and the quantityPackage 50090-5378-00. 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 delayed-release tablets are 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 …
Excerpt only. Read the full label for complete information.
About NDC 50090-5378
- What is NDC 50090-5378?
- 50090-5378 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 202038
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 20 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-7458 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-725 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4895 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 65862-560 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-805 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-806 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-797 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1165 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Redpharm Drug | 67296-1812 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-6870 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-1788 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5361 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-5379 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | HAWAII REPACK, INC. | 85534-0027 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8113 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-5053 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-2645 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | HAWAII REPACK, INC. | 85534-0061 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0406 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-736 |
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