What is NDC 71610-688?

71610-688 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release pellets, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?

249 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 71610-688 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-688Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0688Add 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
71610-688-30	71610068830	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-30)Marketed from Jan 20, 2023
71610-688-43	71610068843	1300 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-43)Marketed from Jun 10, 2024
71610-688-53	71610068853	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-53)Marketed from Jan 20, 2023
71610-688-58	71610068858	650 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-58)Marketed from Jun 10, 2024
71610-688-60	71610068860	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-60)Marketed from Jan 20, 2023
71610-688-80	71610068880	180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-80)Marketed from Jan 20, 2023
71610-688-87	71610068887	2400 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-87)Marketed from Jun 10, 2024

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 — 40 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203481
Marketing start: Jul 3, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 71610-688_1ac7526d-c24f-66d3-e063-6294a90a42d1SPL ID 1ac7526d-c24f-66d3-e063-6294a90a42d1SPL set ID 3e99b78b-7fb8-4514-a3db-58e59cd429d8RxCUI 200329UNII KG60484QX9
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

N471610068830 followed by a unit qualifier and the quantity

Package 71610-0688-30. 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 Jun 13, 2024.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Omeprazole delayed-release capsules, USP, 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 ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-688

What is NDC 71610-688?: 71610-688 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release pellets, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?: 249 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 20 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Amazon.com Services LLC	72288-666	72288-0666-55
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Discount Drug Mart, Inc	53943-038	53943-0038-1453943-0038-42
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	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
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Walgreen Company	0363-4099	00363-4099-03

All 250 Omeprazole NDCs

Other NDCs under ANDA 203481

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

FDA NDC Directory listings under ANDA 203481
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed release pelletsOral	Golden State Medical Supply, Inc.	51407-664
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed release pelletsOral	Golden State Medical Supply, Inc.	51407-814