Zegerid NDC 68012-052

NDC codes

FDA NDC Directory

Product NDC (as listed)68012-052Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68012-0052Add the package segment from the table below.

Product 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..
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021636
Marketing start: Jun 15, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 68012-052_1d076bd0-8cc0-4327-8032-9a307fc89e71SPL ID 1d076bd0-8cc0-4327-8032-9a307fc89e71SPL set ID cd6868b9-5824-442b-8d65-4db29ecb70a4RxCUI 616539, 616541, 646344, 646352, 753557, 753562, 753601, 753603UNII 8MDF5V39QO, KG60484QX9UPC 0368012104308, 0368012102304
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

Current FDA label (SPL), effective Jul 19, 2023.

Indications (excerpt from the label)

ZEGERID for oral suspension and ZEGERID 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. o The efficacy of ZEGERID 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 treatment may…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021636

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021636
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