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NDC 37000-0459-04 Prilosec OTC 20 mg/1 Details
Prilosec OTC 20 mg/1
Prilosec OTC is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is OMEPRAZOLE MAGNESIUM.
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: 37000-0459-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole
Product Information
| NDC | 37000-0459 |
|---|---|
| Product ID | 37000-459_04131ee0-9a20-06ce-e063-6394a90ad46d |
| Associated GPIs | 49270060100620 |
| GCN Sequence Number | 025703 |
| GCN Sequence Number Description | omeprazole magnesium TABLET DR 20 MG ORAL |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 08454 |
| HICL Sequence Number | 011115 |
| HICL Sequence Number Description | OMEPRAZOLE MAGNESIUM |
| Brand/Generic | Brand |
| Proprietary Name | Prilosec OTC |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | OMEPRAZOLE MAGNESIUM |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | OMEPRAZOLE MAGNESIUM |
| Labeler Name | The Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021229 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 37000-0459-04 (37000045904)
| NDC Package Code | 37000-459-04 |
|---|---|
| Billing NDC | 37000045904 |
| Package | 3 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2012-08-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |