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NDC 70436-0190-82 Esomeprazole sodium 40 mg/5mL Details
Esomeprazole sodium 40 mg/5mL
Esomeprazole sodium is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Slate Run Pharmaceuticals, LLC. The primary component is ESOMEPRAZOLE SODIUM.
MedlinePlus Drug Summary
Esomeprazole injection is used 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 adults and children 1 month of age or older who have had damage to their esophagus and are unable to take esomeprazole by mouth. Esomeprazole injection is also used in adults to reduce the risk of further ulcer bleeding after an endoscopy (examination of the inside of the esophagus, stomach, and intestines). Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 70436-0190-82Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Esomeprazole Injection
Product Information
| NDC | 70436-0190 |
|---|---|
| Product ID | 70436-190_0899c795-cde2-c60b-e063-6394a90a518a |
| Associated GPIs | 49270025202140 |
| GCN Sequence Number | 053718 |
| GCN Sequence Number Description | esomeprazole sodium VIAL 40 MG INTRAVEN |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 21432 |
| HICL Sequence Number | 025968 |
| HICL Sequence Number Description | ESOMEPRAZOLE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Esomeprazole sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Esomeprazole sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ESOMEPRAZOLE SODIUM |
| Labeler Name | Slate Run Pharmaceuticals, LLC |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215732 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70436-0190-82 (70436019082)
| NDC Package Code | 70436-190-82 |
|---|---|
| Billing NDC | 70436019082 |
| Package | 10 VIAL in 1 CARTON (70436-190-82) / 5 mL in 1 VIAL (70436-190-80) |
| Marketing Start Date | 2022-02-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |