What is NDC 71610-912?

71610-912 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?

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 71610-912 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-912Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0912Add 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
71610-912-30	7161009123071610091230	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-30)Marketed from Sep 2, 2025
71610-912-53	7161009125371610091253	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-53)Marketed from Sep 2, 2025
71610-912-60	7161009126071610091260	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-60)Marketed from Jun 5, 2025
71610-912-80	7161009128071610091280	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-912-80)Marketed from Sep 2, 2025

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078490
Marketing start: Mar 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 71610-912_3dd6a23e-9d69-1ebb-e063-6394a90ab10dSPL ID 3dd6a23e-9d69-1ebb-e063-6394a90ab10dSPL set ID 3724b8f7-52ff-a5f8-e063-6294a90acf20RxCUI 198051UNII 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

N471610091230 followed by a unit qualifier and the quantity

Package 71610-0912-30. 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 Sep 2, 2025.

Indications (excerpt from the label)

Omeprazole 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 2 years of age and older (1.4) • 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 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-912

What is NDC 71610-912?: 71610-912 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: 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?: 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 078490

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

FDA NDC Directory listings under ANDA 078490
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	NorthStar Rx LLC	16714-630
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NorthStar Rx LLC	16714-634
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals, Inc.	68071-3733
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals, Inc.	68071-5301
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	PHOENIX RX LLC	85509-1644
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Quallent Pharmaceuticals Health LLC	82009-183
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	NorthStar Rx LLC	16714-123
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-4177
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-6720
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-2741
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-6721
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Dr. Reddy's Laboratories Limited	55111-644
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Dr. Reddy's Laboratories Limited	55111-643
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Dr. Reddy's Laboratories Limited	55111-645
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Northwind Health Company, LLC	82868-080
Omeprazole DRomeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0109
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8771
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Redpharm Drug	67296-1939
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-875
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-876

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