Prescription drug · ANDA
Omeprazole and Sodium Bicarbonate NDC 50228-363
Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 · Capsule · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-363-05 | 50228036305 | 500 CAPSULE in 1 BOTTLE (50228-363-05)Marketed from Dec 6, 2016 | |
| 50228-363-30 | 50228036330 | 30 CAPSULE in 1 BOTTLE (50228-363-30)Marketed from Dec 6, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Omeprazole and Sodium Bicarbonate
- Generic name (nonproprietary)
- omeprazole and sodium bicarbonate
- Active ingredients
- Omeprazole — 20 mg/1Sodium bicarbonate — 1100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207476
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 50228-363_25403f99-6570-5b4b-e063-6294a90a9963SPL ID 25403f99-6570-5b4b-e063-6294a90a9963SPL set ID a107804e-b308-4e79-9447-07d93016f70fRxCUI 616539, 616541UNII 8MDF5V39QO, KG60484QX9UPC 0350228364300, 0350228363303
- Pharmacologic class
- Proton Pump Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450228036305followed by a unit qualifier and the quantityPackage 50228-0363-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Omeprazole and sodium bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of trea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207476
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omeprazole/Bicarbonateomeprazole and sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-985 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-364 |
| omeprazole sodium bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-913 |
| omeprazole sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-914 |
| Omeprazole/Bicarbonateomeprazole and sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Westminster Pharmaceuticals, LLC | 69367-196 |