Prescription drug · ANDA

Omeprazole DR (omeprazole) NDC 80425-0169

Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0169Add 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
80425-0169-18042501690130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-1)Marketed from Oct 31, 2014
80425-0169-28042501690260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-2)Marketed from Oct 31, 2014
80425-0169-3804250169034 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-3)Marketed from Oct 31, 2014

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 DRSuffix: DR
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 80425-0169_4cf007cf-ee50-ce69-e063-6394a90a971aSPL ID 4cf007cf-ee50-ce69-e063-6394a90a971aSPL set ID c8bf92c9-1bab-7985-e053-2995a90a0225RxCUI 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

N480425016901 followed by a unit qualifier and the quantity

Package 80425-0169-01. 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 .

Indications (excerpt from the label)

1. Indications and Usage Section INDICATIONS AND USAGE 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year his…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-280
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-3876
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-942

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