Prescription drug · ANDA

Pantoprazole Sodium (pantoprazole) NDC 82009-011

Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Quallent Pharmaceuticals Health LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0011Add 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
82009-011-10820090011101000 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-011-10)Marketed from Jun 6, 2022
82009-011-908200900119090 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-011-90)Marketed from Jun 6, 2022

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)
Pantoprazole Sodium
Generic name (nonproprietary)
pantoprazole
Active ingredients
Pantoprazole sodium — 40 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202882
Marketing start
Listing expires
Other FDA classes
Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 82009-011_48430767-cec0-15e0-e063-6394a90ac032SPL ID 48430767-cec0-15e0-e063-6394a90ac032SPL set ID 643eb498-d916-4fb7-9281-32895575ab36RxCUI 251872, 314200UNII 6871619Q5XUPC 0382009010908, 0382009011905
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

N482009001110 followed by a unit qualifier and the quantity

Package 82009-0011-10. 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 delayed-release tablet 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 delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202882

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

FDA NDC Directory listings under ANDA 202882
ProductStrengthForm · routeLabelerProduct NDC
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-2215
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-654
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-679
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralDIRECT RX72189-112
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-671
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-674
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-2285
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0278
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-0551
Pantoprazole Sodium DRPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralDirect_Rx72189-514
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAvPAK50268-727
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-1572
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-8644
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-653
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-659
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4864
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-668
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-669
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC51655-744
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-831

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Pantoprazole Sodium (pantoprazole) NDC 82009-011 | Med-Code