NDC codes

FDA NDC Directory
Product NDC (as listed)71610-280Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0280Add 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 NDC11-digit (billing)PackageCopy
71610-280-307161002803030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-30)Marketed from Aug 27, 2025
71610-280-537161002805360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-53)Marketed from Aug 27, 2025
71610-280-607161002806090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-60)Marketed from May 22, 2019
71610-280-8071610028080180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-80)Marketed from Aug 27, 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 — 40 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091672
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 71610-280_3d7345e9-323c-c468-e063-6294a90a9aa6SPL ID 3d7345e9-323c-c468-e063-6294a90a9aa6SPL set ID bab55f83-ba03-49a0-842a-19c9976b7fe8RxCUI 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

N471610028030 followed by a unit qualifier and the quantity

Package 71610-0280-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6881
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3007
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6995
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNuCarePharmaceuticals, Inc.68071-2199
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8079
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-2251
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralUnit Dose Solutions, Inc.87441-063
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5501
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPHOENIX RX LLC85509-1396
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralST. MARY'S MEDICAL PARK PHARMACY60760-841
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-820
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-055
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-828
Omeprazole DRomeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0070
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1639
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-501
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4024
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-3876
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-942
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5111

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