Prescription drug · ANDA

Pantoprazole Sodium DR (Pantoprazole sodium) NDC 80425-0406

Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0406Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0406Add 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
80425-0406-1804250406018042504060130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-1)Marketed from Jun 27, 2024
80425-0406-2804250406028042504060260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-2)Marketed from Jun 27, 2024
80425-0406-3804250406038042504060390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0406-3)Marketed from Jun 27, 2024

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)
Pantoprazole Sodium DRSuffix: DR
Generic name (nonproprietary)
pantoprazole sodium
Active ingredients
Pantoprazole sodium — 20 mg/1
Dosage form
Tablet, 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 202038
Marketing start
Listing expires
Other FDA classes
Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 80425-0406_1c4616ae-982f-d4b6-e063-6294a90a38f6SPL ID 1c4616ae-982f-d4b6-e063-6294a90a38f6SPL set ID 1c46140c-2399-5ca3-e063-6394a90af33bRxCUI 251872UNII 6871619Q5X
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

N480425040601 followed by a unit qualifier and the quantity

Package 80425-0406-01. 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)

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). Fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0406

What is NDC 80425-0406?
80425-0406 is the product NDC for Pantoprazole Sodium DR (pantoprazole sodium), Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pantoprazole Sodium DR (Pantoprazole Sodium).
What is the active ingredient?
Pantoprazole sodium.
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 Pantoprazole Sodium DR?
6 other product NDCs are listed under this name. See all Pantoprazole Sodium 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 Pantoprazole Sodium DR NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pantoprazole Sodium DRPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralDirect_Rx72189-51472189-0514-3072189-0514-90
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-027880425-0278-0180425-0278-0280425-0278-03
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-008580425-0085-03
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-013380425-0133-0180425-0133-0280425-0133-03
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-016280425-0162-0180425-0162-0280425-0162-03
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-017980425-0179-0280425-0179-03

Other NDCs under ANDA 202038

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

FDA NDC Directory listings under ANDA 202038
ProductStrengthForm · routeLabelerProduct NDC
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralMajor Pharmaceuticals0904-7458
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-725
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4895
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAurobindo Pharma Limited65862-560
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-805
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-806
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC51655-797
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-1165
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralRedpharm Drug67296-1812
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralMajor Pharmaceuticals0904-6870
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-1788
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-5361
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-5379
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralHAWAII REPACK, INC.85534-0027
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-5378
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8113
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-5053
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralCardinal Health 107, LLC55154-2645
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralHAWAII REPACK, INC.85534-0061
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-736

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