Prescription drug · NDA
Zegerid (Omeprazole and sodium bicarbonate) NDC 68012-052
Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 · Powder, For suspension · Oral · Santarus, Inc..
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Zegerid
- Generic name (nonproprietary)
- omeprazole and sodium bicarbonate
- Active ingredients
- Omeprazole — 20 mg/1Sodium bicarbonate — 1680 mg/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Santarus, Inc..NDC labeler code 68012
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021636
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 68012-052_29e837b9-23e9-4769-a025-46ab153610c4SPL ID 29e837b9-23e9-4769-a025-46ab153610c4
- 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.
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68012-052
- What is NDC 68012-052?
- 68012-052 is the product NDC for Zegerid, Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 powder, for suspension, listed with the FDA by Santarus, Inc...
- What drug is associated with this NDC?
- Zegerid (Omeprazole and sodium bicarbonate).
- What is the active ingredient?
- Omeprazole, Sodium bicarbonate.
- Who is the labeler?
- Santarus, Inc.., NDC labeler code 68012. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zegerid?
- 1 other product NDC are listed under this name. See all Zegerid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zegerid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zegeridomeprazole and sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Santarus, Inc.. | 68012-054 | 68012-0054-03 |
Other NDCs under NDA 021636
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 |
|---|---|---|---|---|
| Zegeridomeprazole and sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Santarus, Inc.. | 68012-054 |