Prescription drug · ANDA
pantoprazole sodium NDC 70010-190
Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-190-09 | 70010019009 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-09)Marketed from Apr 12, 2024 | |
| 70010-190-10 | 70010019010 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-10)Marketed from Apr 12, 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
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217282
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 70010-190_4ec4732c-38ba-bcc3-e063-6294a90a823cSPL ID 4ec4732c-38ba-bcc3-e063-6294a90a823cSPL set ID 8f2fb647-15bc-41cb-84a4-02e956e614fcRxCUI 251872, 314200UNII 6871619Q5XUPC 0370010190092, 0370010191099
- 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
N470010019009followed by a unit qualifier and the quantityPackage 70010-0190-09. 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 217282
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 | Tablet, Delayed releaseOral | Granules Pharmaceuticals Inc. | 70010-191 |