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NDC 65219-0433-15 Pantoprazole Sodium 40 mg/10mL Details
Pantoprazole Sodium 40 mg/10mL
Pantoprazole Sodium is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is PANTOPRAZOLE SODIUM.
MedlinePlus Drug Summary
Pantoprazole injection is used as a short-term treatment to treat gastroesophageal reflux disease (GERD; a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus [the tube between the throat and stomach]) in people who have had damage to their esophagus and who are unable to take pantoprazole by mouth. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas and small intestine that caused increased production of stomach acid). Pantoprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 65219-0433-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pantoprazole Injection
Product Information
| NDC | 65219-0433 |
|---|---|
| Product ID | 65219-433_5945c78e-4682-417b-85e9-efdfe8b087d7 |
| Associated GPIs | 49270070102120 |
| GCN Sequence Number | 047635 |
| GCN Sequence Number Description | pantoprazole sodium VIAL 40 MG INTRAVEN |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 13025 |
| HICL Sequence Number | 022008 |
| HICL Sequence Number Description | PANTOPRAZOLE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Pantoprazole Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pantoprazole Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/10mL |
| Substance Name | PANTOPRAZOLE SODIUM |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090296 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0433-15 (65219043315)
| NDC Package Code | 65219-433-15 |
|---|---|
| Billing NDC | 65219043315 |
| Package | 10 VIAL in 1 CARTON (65219-433-15) / 10 mL in 1 VIAL (65219-433-01) |
| Marketing Start Date | 2021-08-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |