Prescription drug · ANDA

Omeprazole DR (Omeprazole) NDC 80425-0070

Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0070Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0070Add 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
80425-0070-1804250070018042500700130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-1)Marketed from Oct 31, 2014
80425-0070-2804250070028042500700260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-2)Marketed from Oct 31, 2014
80425-0070-38042500700380425007003120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-3)Marketed from Oct 31, 2014
80425-0070-4804250070048042500700490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0070-4)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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
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 80425-0070_2a98d9c1-b775-40b1-e063-6294a90a20e4SPL ID 2a98d9c1-b775-40b1-e063-6294a90a20e4SPL set ID af85afda-6b0c-d657-e053-2a95a90afb4bRxCUI 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

N480425007001 followed by a unit qualifier and the quantity

Package 80425-0070-01. 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 1 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 h…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0070

What is NDC 80425-0070?
80425-0070 is the product NDC for Omeprazole DR (omeprazole), Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Omeprazole DR (Omeprazole).
What is the active ingredient?
Omeprazole.
Who is the labeler?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 DR?
3 other product NDCs are listed under this name. See all Omeprazole DR 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 DR NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Omeprazole DRomeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-007180425-0071-0180425-0071-0280425-0071-03
Omeprazole DRomeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-010980425-0109-01
Omeprazole DRomeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-016980425-0169-0180425-0169-0280425-0169-03

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 40 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8079
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-2769
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-3876
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5111
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5501
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralST. MARY'S MEDICAL PARK PHARMACY60760-841
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-820
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-828
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNuCarePharmaceuticals, Inc.68071-2199
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3007
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4024
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralGlenmark Pharmaceuticals Inc., USA68462-395
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralGlenmark Pharmaceuticals Inc., USA68462-396
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralGlenmark Pharmaceuticals Inc., USA68462-397
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6881
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6995
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-0199
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-2251
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-501
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0299

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