Prescription drug · ANDA
Pantoprazole sodium delayed-release NDC 70756-018
Pantoprazole sodium 20 mg/1 · Tablet · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-018-51 | 70756001851 | 500 TABLET in 1 BOTTLE (70756-018-51)Marketed from Apr 25, 2024 | |
| 70756-018-90 | 70756001890 | 90 TABLET in 1 BOTTLE (70756-018-90)Marketed from Apr 25, 2024 |
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 delayed-release
- Generic name (nonproprietary)
- pantoprazole sodium delayed-release
- Active ingredients
- Pantoprazole sodium — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lifestar Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215880
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70756-018_2c507c43-c033-4b6e-b954-f0f2fb617289SPL ID 2c507c43-c033-4b6e-b954-f0f2fb617289SPL set ID 0502f935-af7a-4f1e-8c3e-29e20647c885RxCUI 251872, 314200UNII 6871619Q5XUPC 0370756019121, 0370756019909
- 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
N470756001851followed by a unit qualifier and the quantityPackage 70756-0018-51. 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)
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 is 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 relief of erosive esophagitis (E…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215880
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 delayed-release | Pantoprazole sodium 40 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-019 |