omeprazole NDC 31722-528

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0528Add 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
31722-528-01	31722052801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-01)Marketed from Sep 26, 2019
31722-528-30	31722052830	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-30)Marketed from Sep 26, 2019

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): omeprazole
Generic name (nonproprietary): omeprazole
Active ingredients: Omeprazole — 20 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204012
Marketing start: Sep 26, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 31722-528_2b439e93-9a24-e64a-e063-6394a90a634fSPL ID 2b439e93-9a24-e64a-e063-6394a90a634fSPL set ID 0c6e00a2-31e8-4e84-928d-80e69a5fc634RxCUI 198051, 199119UNII KG60484QX9UPC 0331722528306, 0331722527309
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

N431722052801 followed by a unit qualifier and the quantity

Package 31722-0528-01. 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 Jan 9, 2025.

Indications (excerpt from the label)

Omeprazole delayed-release capsules are 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 2 years of age and older ( 1.4 ) • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5 ) • Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) • Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204012

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

FDA NDC Directory listings under ANDA 204012
Product	Strength	Form · route	Labeler	Product NDC
omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Camber Pharmaceuticals, Inc.	31722-527