What is NDC 0781-2868?

0781-2868 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Sandoz Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Omeprazole?

252 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole NDC 0781-2868 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-2868Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-2868Add 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
0781-2868-01	0078128680100781286801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-01)Marketed from Aug 1, 2019
0781-2868-10	0078128681000781286810	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-10)Marketed from Jul 1, 2019
0781-2868-31	0078128683100781286831	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-31)Marketed from Jul 1, 2019
0781-2868-92	0078128689200781286892	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2868-92)Marketed from Jul 1, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075757
Marketing start: Jul 1, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0781-2868_b182f298-e28f-434b-b6f1-ecfac29d495eSPL ID b182f298-e28f-434b-b6f1-ecfac29d495eSPL set ID 516170d4-4913-4577-a2d2-f5c52d1e79c6RxCUI 198051, 199119UNII KG60484QX9UPC 0307812868317, 0307812859315
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

N400781286801 followed by a unit qualifier and the quantity

Package 00781-2868-01. 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 Dec 31, 2024.

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)

About NDC 0781-2868

What is NDC 0781-2868?: 0781-2868 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Sandoz Inc. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Omeprazole.
What is the active ingredient?: Omeprazole.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omeprazole?: 252 other product NDCs are listed under this name. See all Omeprazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Omeprazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Chain Drug Marketing Association, Inc.	83324-309	83324-0309-1483324-0309-42
Omeprazole	Omeprazole 20 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Amazon.com Services LLC	72288-666	72288-0666-5572288-0666-74
Omeprazoleomeprazole magnesium	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	YYBA CORP	73581-015	73581-0015-03
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Discount Drug Mart, Inc	53943-038	53943-0038-1453943-0038-42
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Amazon.com Services LLC	72288-934	72288-0934-01
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	H E B	59640-699	59640-0699-0159640-0699-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-063	87441-0063-01
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Safeway	21130-783	21130-0783-0121130-0783-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Phharmaceuticals Inc.	68788-4104	68788-4104-0168788-4104-0268788-4104-03+4 more
omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-606	72288-0606-03

All 253 Omeprazole NDCs

Other NDCs under ANDA 075757

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

FDA NDC Directory listings under ANDA 075757
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Sandoz Inc	0781-2790
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-868
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	82804-166
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	QPharma Inc	42708-170
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Sandoz Inc	0781-2785
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-9609
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Sandoz Inc	0781-2859
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Northwind Health Company, LLC	51655-893
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8864
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Chartwell RX, LLC	62135-559