Prescription drug · NDA
Protonix Delayed-Release (pantoprazole sodium) NDC 0008-0844
Pantoprazole sodium 40 mg/1 · Granule, Delayed release · Oral · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0008-0844-02 | 00008084402 | 30 PACKET in 1 CARTON (0008-0844-02) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01)Marketed from Feb 29, 2008 |
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)
- Protonix Delayed-ReleaseSuffix: Delayed-Release
- Generic name (nonproprietary)
- pantoprazole sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Granule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022020
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0008-0844_b1adaee5-9353-48ce-bde4-f169a3787e30SPL ID b1adaee5-9353-48ce-bde4-f169a3787e30SPL set ID 08098cb2-c048-4640-f387-6beec4a38936RxCUI 251872, 284400, 314200, 352125, 763306, 763308UNII 6871619Q5XUPC 0300080843819, 0300080841815
- 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
N400008084402followed by a unit qualifier and the quantityPackage 00008-0844-02. 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)
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX 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) PROTONIX 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 …
Excerpt only. Read the full label for complete information.