NDC codes

FDA NDC Directory
Product NDC (as listed)70515-625Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70515-0625Add 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 NDC11-digit (billing)PackageCopy
70515-625-017051506250130 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)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 — 2.5 mg/1
Dosage form
Granule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022056
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 70515-625_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

N470515062501 followed by a unit qualifier and the quantity

Package 70515-0625-01. 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 .

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
ProductStrengthForm · routeLabelerProduct NDC
Prilosecomeprazole magnesiumOmeprazole magnesium 10 mg/1Granule, Delayed releaseOralCovis Pharma US, Inc70515-610

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