Prescription drug · ANDA
Pantoprazole Sodium (pantoprazole) NDC 71335-0551
Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0551-1 | 71335055101 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-1)Marketed from Sep 15, 2020 | |
| 71335-0551-2 | 71335055102 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-2)Marketed from Jul 31, 2020 | |
| 71335-0551-3 | 71335055103 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-3)Marketed from Jun 17, 2020 | |
| 71335-0551-4 | 71335055104 | 58 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-4)Marketed from Apr 3, 2024 | |
| 71335-0551-5 | 71335055105 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-5)Marketed from Mar 10, 2022 | |
| 71335-0551-6 | 71335055106 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-6)Marketed from Apr 3, 2024 | |
| 71335-0551-7 | 71335055107 | 10 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-7)Marketed from Apr 3, 2024 | |
| 71335-0551-8 | 71335055108 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-8)Marketed from Apr 3, 2024 | |
| 71335-0551-9 | 71335055109 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-9)Marketed from Apr 3, 2024 |
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 Sodium
- Generic name (nonproprietary)
- pantoprazole
- Active ingredients
- Pantoprazole sodium — 40 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202882
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0551_9bbd7c7e-79e2-476c-83d6-eec38a53fb63SPL ID 9bbd7c7e-79e2-476c-83d6-eec38a53fb63SPL set ID 617bb464-5357-472f-8e9d-61aae5b2ebefRxCUI 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
N471335055101followed by a unit qualifier and the quantityPackage 71335-0551-01. 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 delayed-release tablet 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 healin…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202882
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 Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2215 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-654 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-679 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-112 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-671 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-674 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2285 |
| Pantoprazole Sodium DRpantoprazole sodium | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0278 |
| Pantoprazole Sodium DR | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Direct_Rx | 72189-514 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | AvPAK | 50268-727 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1572 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8644 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-653 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-659 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4864 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-668 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 40 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-669 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 51655-744 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-831 |
| Pantoprazole Sodiumpantoprazole | Pantoprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | XLCare Pharmaceuticals Inc. | 72865-229 |
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