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NDC 68382-0411-16 Omeprazole 10 mg/1 Details
Omeprazole 10 mg/1
Omeprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is OMEPRAZOLE.
MedlinePlus Drug Summary
Prescription omeprazole is used alone or with other medications to treat the symptoms of 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 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 68382-0411-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omeprazole
Product Information
| NDC | 68382-0411 |
|---|---|
| Product ID | 68382-411_d0074baa-52cb-4039-9bd8-966a36ff70da |
| Associated GPIs | 49270060006510 |
| GCN Sequence Number | 043136 |
| GCN Sequence Number Description | omeprazole CAPSULE DR 10 MG ORAL |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 92989 |
| HICL Sequence Number | 004673 |
| HICL Sequence Number Description | OMEPRAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Omeprazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Omeprazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | OMEPRAZOLE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091352 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0411-16 (68382041116)
| NDC Package Code | 68382-411-16 |
|---|---|
| Billing NDC | 68382041116 |
| Package | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16) |
| Marketing Start Date | 2012-11-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |