Prescription drug · NDA
Zegerid (Omeprazole and sodium bicarbonate) NDC 68012-054
Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1 · Powder, For suspension · Oral · Santarus, Inc..
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68012-054-03 | 6801200540368012005403 | 3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jun 15, 2014 |
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)
- Zegerid
- Generic name (nonproprietary)
- omeprazole and sodium bicarbonate
- Active ingredients
- Omeprazole — 40 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 68012-054_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.
- NDC on a medical claim
N468012005403followed by a unit qualifier and the quantityPackage 68012-0054-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68012-054
- What is NDC 68012-054?
- 68012-054 is the product NDC for Zegerid, Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1 powder, for suspension, listed with the FDA by Santarus, Inc... It has 1 package NDC, shown above in 10- and 11-digit form.
- 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 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Santarus, Inc.. | 68012-052 | — |
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 20 mg/1; Sodium bicarbonate 1680 mg/1 | Powder, For suspensionOral | Santarus, Inc.. | 68012-052 |