What is NDC 85534-0037?

85534-0037 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by HAWAII REPACK, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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 85534-0037 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0037Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0037Add 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
85534-0037-0	8553400370085534003700	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0037-0)Marketed from Jul 13, 2026
85534-0037-1	8553400370185534003701	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0037-1)Marketed from Jul 13, 2026
85534-0037-2	8553400370285534003702	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0037-2)Marketed from Jul 13, 2026
85534-0037-3	8553400370385534003703	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0037-3)Marketed from Jul 13, 2026

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 — 40 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091672
Marketing start: Oct 31, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 85534-0037_567a8302-5812-1266-e063-6294a90a2157SPL ID 567a8302-5812-1266-e063-6294a90a2157SPL set ID 9359e826-5263-44fc-8dd3-9d0852fe42d6RxCUI 198051, 199119, 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

N485534003700 followed by a unit qualifier and the quantity

Package 85534-0037-00. 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 13, 2026.

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 ) 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 u…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0037

What is NDC 85534-0037?: 85534-0037 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by HAWAII REPACK, 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?: HAWAII REPACK, INC., NDC labeler code 85534. 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 091672

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

FDA NDC Directory listings under ANDA 091672
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8079
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-2769
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-3876
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-5111
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-5501
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-841
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	63187-820
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	63187-828
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	NuCarePharmaceuticals, Inc.	68071-2199
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-3007
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4024
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-395
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-396
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-397
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-6881
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-6995
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-0199
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-2251
Omeprazole	Omeprazole 10 mg/1	Capsule, Delayed releaseOral	Proficient Rx LP	71205-501
Omeprazole	Omeprazole 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-0299

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