What is NDC 85509-1644?

85509-1644 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by PHOENIX RX LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

PHOENIX RX LLC, NDC labeler code 85509. 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 85509-1644 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85509-1644Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85509-1644Add 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
85509-1644-1	8550916440185509164401	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-1)Marketed from Jul 29, 2025
85509-1644-3	8550916440385509164403	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-3)Marketed from Jul 29, 2025
85509-1644-6	8550916440685509164406	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-6)Marketed from Jul 29, 2025
85509-1644-9	8550916440985509164409	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-9)Marketed from Jul 29, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: PHOENIX RX LLCNDC labeler code 85509
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078490
Marketing start: Mar 6, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 85509-1644_3b19d244-3cd1-0813-e063-6394a90ac153SPL ID 3b19d244-3cd1-0813-e063-6394a90ac153SPL set ID 3b19d724-821b-61dc-e063-6294a90aa4d3RxCUI 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

N485509164401 followed by a unit qualifier and the quantity

Package 85509-1644-01. 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 Jul 29, 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 85509-1644

What is NDC 85509-1644?: 85509-1644 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by PHOENIX RX 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?: PHOENIX RX LLC, NDC labeler code 85509. 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	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	Aphena Pharma Solutions - Tennessee, LLC	71610-912
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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