Prescription drug · ANDA
Pantoprazole NDC 68071-3776
Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3776-3 | 68071377603 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3776-3)Marketed from Jan 29, 2025 | |
| 68071-3776-6 | 68071377606 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3776-6)Marketed from Jan 17, 2025 |
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
- Generic name (nonproprietary)
- pantoprazole
- Active ingredients
- Pantoprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077619
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3776_2cdd5c73-14c7-6010-e063-6394a90a83a1SPL ID 2cdd5c73-14c7-6010-e063-6394a90a83a1SPL set ID 2bed1bae-519f-1bb9-e063-6294a90a795bRxCUI 251872UNII 6871619Q5XUPC 0368071377668
- 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
N468071377603followed by a unit qualifier and the quantityPackage 68071-3776-03. 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 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 symptomatic relief …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077619
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 | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-574 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8505 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1332 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0552 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Dr.Reddy's Laboratories Limited | 55111-332 |
| Pantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Dr.Reddy's Laboratories Limited | 55111-333 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-0789 |
| Pantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3995 |
| Pantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3524 |
| Pantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NorthStar RxLLC | 72603-177 |
| Pantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NorthStar RxLLC | 72603-178 |