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NDC 68382-0503-04 omeprazole and sodium bicarbonate 20; 1100 mg/1; mg/1 Details
omeprazole and sodium bicarbonate 20; 1100 mg/1; mg/1
omeprazole and sodium bicarbonate is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is OMEPRAZOLE; SODIUM BICARBONATE.
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: 68382-0503-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omeprazole
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic in certain conditions. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 68382-0503-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 68382-0503 |
|---|---|
| Product ID | 68382-503_07494f08-60c9-4350-a91e-944730e677e0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | omeprazole and sodium bicarbonate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | omeprazole and sodium bicarbonate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 20; 1100 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | OMEPRAZOLE; SODIUM BICARBONATE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203345 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0503-04 (68382050304)
| NDC Package Code | 68382-503-04 |
|---|---|
| Billing NDC | 68382050304 |
| Package | 3 BOTTLE in 1 CARTON (68382-503-04) / 14 CAPSULE in 1 BOTTLE |
| Marketing Start Date | 2018-07-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |