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NDC 64380-0183-02 Omeprazole/Sodium Bicarbonate 40; 1680 mg/1720mg; mg/1720mg Details
Omeprazole/Sodium Bicarbonate 40; 1680 mg/1720mg; mg/1720mg
Omeprazole/Sodium Bicarbonate is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Strides Pharma Science Limited. 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: 64380-0183-02Last 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: 64380-0183-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sodium Bicarbonate
Product Information
| NDC | 64380-0183 |
|---|---|
| Product ID | 64380-183_2ac68a93-2f3b-46aa-a874-c109ad1bfefe |
| Associated GPIs | |
| GCN Sequence Number | 060474 |
| GCN Sequence Number Description | omeprazole/sodium bicarbonate PACKET 40-1680MG ORAL |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 26635 |
| HICL Sequence Number | 033512 |
| HICL Sequence Number Description | OMEPRAZOLE/SODIUM BICARBONATE |
| Brand/Generic | Generic |
| Proprietary Name | Omeprazole/Sodium Bicarbonate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | omeprazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 40; 1680 |
| Active Ingredient Units | mg/1720mg; mg/1720mg |
| Substance Name | OMEPRAZOLE; SODIUM BICARBONATE |
| Labeler Name | Strides Pharma Science Limited |
| 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 | ANDA079182 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64380-0183-02 (64380018302)
| NDC Package Code | 64380-183-02 |
|---|---|
| Billing NDC | 64380018302 |
| Package | 30 POUCH in 1 CARTON (64380-183-02) / 40 mg in 1 POUCH (64380-183-01) |
| Marketing Start Date | 2022-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 13.1759 |
| Pricing Unit | EA |
| Effective Date | 2023-12-20 |
| NDC Description | OMEPRAZOLE-BICARB 40-1,680 PKT |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |