Over-the-counter drug · ANDA
Omeprazole And Sodium Bicarbonate NDC 58602-725
Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 · Capsule · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-725-05 | 5860207250558602072505 | 1 BOTTLE in 1 CARTON (58602-725-05) / 14 CAPSULE in 1 BOTTLEMarketed from Dec 22, 2023 | |
| 58602-725-57 | 5860207255758602072557 | 2 BOTTLE in 1 CARTON (58602-725-57) / 14 CAPSULE in 1 BOTTLEMarketed from Dec 22, 2023 | |
| 58602-725-60 | 5860207256058602072560 | 3 BOTTLE in 1 CARTON (58602-725-60) / 14 CAPSULE in 1 BOTTLEMarketed from Dec 22, 2023 |
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
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204923
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-725_48c99760-39f6-4e1f-ae95-16a52fc10898SPL ID 48c99760-39f6-4e1f-ae95-16a52fc10898SPL set ID 88ad2e92-2228-49b2-bcee-1770fd30cb14RxCUI 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
N458602072505followed by a unit qualifier and the quantityPackage 58602-0725-05. 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)
Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect
Excerpt only. Read the full label for complete information.
About NDC 58602-725
- What is NDC 58602-725?
- 58602-725 is the product NDC for Omeprazole And Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Aurohealth 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?
- Aurohealth LLC, NDC labeler code 58602. 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 bicarbonateomeprazole, sodium bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Meijer Distribution Inc | 41250-938 | 41250-0938-03 |
| Omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate | Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | H E B | 37808-732 | 37808-0732-0137808-0732-03 |
Other NDCs under ANDA 204923
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 | Aurohealth LLC | 58602-732 |