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NDC 35573-0428-80 Pantoprazole Sodium 40 mg/1 Details
Pantoprazole Sodium 40 mg/1
Pantoprazole Sodium is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals, LLC. The primary component is PANTOPRAZOLE SODIUM.
MedlinePlus Drug Summary
Pantoprazole is used to treat damage from 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 adults and children 5 years of age and older. Pantoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. 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: 35573-0428-80Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pantoprazole
Product Information
| NDC | 35573-0428 |
|---|---|
| Product ID | 35573-428_d004eeef-231d-461b-8149-0f9ca1801420 |
| Associated GPIs | 49270070100620 |
| GCN Sequence Number | 027462 |
| GCN Sequence Number Description | pantoprazole sodium TABLET DR 40 MG ORAL |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 40120 |
| 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 | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | PANTOPRAZOLE SODIUM |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Pharmaceutical Class | Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202038 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 35573-0428-80 (35573042880)
| NDC Package Code | 35573-428-80 |
|---|---|
| Billing NDC | 35573042880 |
| Package | 10 BLISTER PACK in 1 CARTON (35573-428-80) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2020-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.05264 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | PANTOPRAZOLE SOD DR 40 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |