Prescription drug · ANDA

Pantoprazole Sodium (Pantoprazole) NDC 71610-653

Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-653Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0653Add 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
71610-653-30716100653307161006533030 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30)Marketed from Jul 14, 2022
71610-653-53716100653537161006535360 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53)Marketed from Jul 14, 2022
71610-653-60716100653607161006536090 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60)Marketed from Jul 14, 2022
71610-653-807161006538071610065380180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80)Marketed from Jul 14, 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
Labeler
Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
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 71610-653_6c0bca16-d681-48d1-a07a-93d9d0f3acefSPL ID 6c0bca16-d681-48d1-a07a-93d9d0f3acefSPL set ID e3f711d8-b9d3-46a6-8bf9-6af1cc77003eRxCUI 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

N471610065330 followed by a unit qualifier and the quantity

Package 71610-0653-30. 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 Tablet 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-653

What is NDC 71610-653?
71610-653 is the product NDC for Pantoprazole Sodium (pantoprazole), Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?
Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 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 20 mg/1Tablet, Delayed releaseOralHAWAII REPACK, INC.85534-0062
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

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