Prescription drug · ANDA

Pantoprazole Sodium (Pantoprazole) NDC 85534-0062

Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · HAWAII REPACK, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)85534-0062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85534-0062Add 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
85534-0062-0855340062008553400620010 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-0)Marketed from Jun 25, 2026
85534-0062-1855340062018553400620120 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-1)Marketed from Jun 25, 2026
85534-0062-2855340062028553400620230 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-2)Marketed from Jun 25, 2026
85534-0062-3855340062038553400620360 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-3)Marketed from Jun 25, 2026
85534-0062-4855340062048553400620490 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-4)Marketed from Jun 25, 2026
85534-0062-58553400620585534006205120 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0062-5)Marketed from Jun 25, 2026

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
Generic name (nonproprietary)
pantoprazole
Active ingredients
Pantoprazole sodium — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
HAWAII REPACK, INC.NDC labeler code 85534
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 85534-0062_553e4a15-6652-7588-e063-6294a90a6086SPL ID 553e4a15-6652-7588-e063-6294a90a6086SPL set ID f85e6d64-1ddc-4f4a-86dc-0749081a6a5fRxCUI 251872, 314200UNII 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

N485534006200 followed by a unit qualifier and the quantity

Package 85534-0062-00. 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)

About NDC 85534-0062

What is NDC 85534-0062?
85534-0062 is the product NDC for Pantoprazole Sodium (pantoprazole), Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by HAWAII REPACK, INC.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pantoprazole Sodium (Pantoprazole).
What is the active ingredient?
Pantoprazole sodium.
Who is the labeler?
HAWAII REPACK, INC., NDC labeler code 85534. 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?
135 other product NDCs are listed under this name. See all Pantoprazole Sodium 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pantoprazole SodiumPantoprazole sodium 40 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousAvenacy, LLC83634-75183634-0751-10
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralCardinal Health 107, LLC55154-028955154-0289-00
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAvPAK50268-72750268-0727-10
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-06687441-0066-01
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralUnit Dose Solutions, Inc.87441-06587441-0065-01
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralCoupler LLC67046-034767046-0347-03
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralCoupler LLC67046-053667046-0536-03
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralSafecor Health LLC48433-08148433-0081-20
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNorthStar Rx LLC72603-74672603-0746-0172603-0746-02
Pantoprazole SodiumPantoprazole sodium 40 mg/10mLInjection, Powder, For solutionIntravenousDevatis Inc.73043-02073043-0020-0173043-0020-1073043-0020-25

All 136 Pantoprazole Sodium NDCs

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 20 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC51655-744
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0278
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAvPAK50268-727
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4864
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-831
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-0551
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-5794
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-5793
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-1572
Pantoprazole Sodium DRPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralDirect_Rx72189-514
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 releaseOralHAWAII REPACK, INC.85534-0028
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0133
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 releaseOralXLCare Pharmaceuticals Inc.72865-229
Pantoprazole SodiumpantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralXLCare Pharmaceuticals Inc.72865-230
Pantoprazole Sodium DRpantoprazole sodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0162
Pantoprazole SodiumpantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralQuallent Pharmaceuticals Health LLC82009-010

Showing 20 of 35.

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