Prilosec (omeprazole magnesium) NDC 70515-610

NDC codes

FDA NDC Directory

Product NDC (as listed)70515-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70515-0610Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
70515-610-01	70515061001	30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01)Marketed from Aug 25, 2017

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): Prilosec
Generic name (nonproprietary): omeprazole magnesium
Active ingredients: Omeprazole magnesium — 10 mg/1
Dosage form: Granule, Delayed release
Route: Oral
Labeler: Covis Pharma US, Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022056
Marketing start: Aug 25, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 70515-610_296db0e8-af6e-4053-874d-2a7c8f7aba50SPL ID 296db0e8-af6e-4053-874d-2a7c8f7aba50SPL set ID b6761f84-53ac-4745-a8c8-1e5427d7e179RxCUI 797058, 797061, 797063, 797065UNII 426QFE7XLK
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

N470515061001 followed by a unit qualifier and the quantity

Package 70515-0610-01. 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 Mar 19, 2024.

Indications (excerpt from the label)

PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults ( 1.1 ) • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) • Treatment of active benign gastric ulcer in adults ( 1.3 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older ( 1.4 ) • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) • Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer PR…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022056

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

FDA NDC Directory listings under NDA 022056
Product	Strength	Form · route	Labeler	Product NDC
Prilosecomeprazole magnesium	Omeprazole magnesium 2.5 mg/1	Granule, Delayed releaseOral	Covis Pharma US, Inc	70515-625