Prescription drug · ANDA
Omeprazole and Sodium Bicarbonate NDC 85509-1031
Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 · Capsule · Oral · PHOENIX RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85509-1031-1 | 8550910310185509103101 | 15 CAPSULE in 1 BOTTLE (85509-1031-1)Marketed from Jul 30, 2025 | |
| 85509-1031-3 | 8550910310385509103103 | 30 CAPSULE in 1 BOTTLE (85509-1031-3)Marketed from Jul 30, 2025 | |
| 85509-1031-6 | 8550910310685509103106 | 60 CAPSULE in 1 BOTTLE (85509-1031-6)Marketed from Jul 30, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- PHOENIX RX LLCNDC labeler code 85509
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204228
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 85509-1031_3b2bf542-9d8a-6ff6-e063-6394a90a3faeSPL ID 3b2bf542-9d8a-6ff6-e063-6394a90a3faeSPL set ID 3b2bf501-fd81-6ffa-e063-6394a90afe42RxCUI 616539UNII KG60484QX9, 8MDF5V39QO
- 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
N485509103101followed by a unit qualifier and the quantityPackage 85509-1031-01. 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 capsules 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 wee…
Excerpt only. Read the full label for complete information.
About NDC 85509-1031
- What is NDC 85509-1031?
- 85509-1031 is the product NDC for Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by PHOENIX RX LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole and Sodium Bicarbonate.
- What is the active ingredient?
- Omeprazole, Sodium bicarbonate.
- Who is the labeler?
- PHOENIX RX LLC, NDC labeler code 85509. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omeprazole and Sodium Bicarbonate?
- 19 other product NDCs are listed under this name. See all Omeprazole and Sodium Bicarbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omeprazole and Sodium Bicarbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omeprazole And Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Aurohealth LLC | 58602-732 | 58602-0732-0558602-0732-5758602-0732-60 |
| omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Amazon.com Services LLC | 72288-564 | 72288-0564-03 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | ANI Pharmaceuticals, Inc. | 70954-797 | 70954-0797-20 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | ANI Pharmaceuticals, Inc. | 70954-798 | 70954-0798-20 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | PHOENIX RX LLC | 85509-1032 | 85509-1032-0185509-1032-0385509-1032-06 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Dr. Reddy's Laboratories Inc., | 43598-010 | 43598-0010-0143598-0010-1443598-0010-28+1 more |
| Omeprazole and Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Dr. Reddy's Laboratories Inc., | 43598-307 | 43598-0307-0143598-0307-1443598-0307-28+1 more |
| Omeprazole and Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Dr. Reddy's Laboratories Inc., | 75907-138 | 75907-0138-42 |
| Omeprazole And Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Aurohealth LLC | 58602-725 | 58602-0725-0558602-0725-5758602-0725-60 |
| omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Meijer Distribution Inc | 41250-938 | 41250-0938-03 |
Other NDCs under ANDA 204228
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 and Sodium Bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-031 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-032 |
| Omeprazole and Sodium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | PHOENIX RX LLC | 85509-1032 |
| Omeprazole/Sodiium Bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | CapsuleOral | Direct_rx | 72189-568 |