Prescription drug · ANDA
Pantoprazole Sodium NDC 43353-027
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-027-30 | 43353002730 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-30)Marketed from Apr 29, 2015 | |
| 43353-027-53 | 43353002753 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53)Marketed from Apr 29, 2015 | |
| 43353-027-60 | 43353002760 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-60)Marketed from Apr 19, 2016 | |
| 43353-027-80 | 43353002780 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-80)Marketed from Apr 19, 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 sodium
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078281
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 43353-027_244f530f-f490-4ad9-ad20-bf541fb4f95fSPL ID 244f530f-f490-4ad9-ad20-bf541fb4f95fSPL set ID c9bc288b-e84c-4e31-a769-c87a59226086RxCUI 251872, 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
N443353002730followed by a unit qualifier and the quantityPackage 43353-0027-30. 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, USP are indicated for: Pantoprazole 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 Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole 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 (EE). For those …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078281
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 | Lannett Company, Inc. | 62175-617 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Lannett Company, Inc. | 62175-618 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-938 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-1746 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-612 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-613 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Chartwell RX, LLC | 62135-533 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Chartwell RX, LLC | 62135-534 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-585 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-639 |
| Pantoprazole Sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-4346 |
| Pantoprazole Sodium | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-086 |