Prescription drug · ANDA

Pantoprazole Sodium (Pantoprazole) NDC 72189-112

Pantoprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · DIRECT RX

NDC codes

FDA NDC Directory
Product NDC (as listed)72189-112Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0112Add 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
72189-112-30721890112307218901123030 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-30)Marketed from Jun 12, 2020
72189-112-60721890112607218901126060 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-60)Marketed from Jun 12, 2020
72189-112-90721890112907218901129090 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-90)Marketed from Jun 12, 2020

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 — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
DIRECT RXNDC labeler code 72189
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 72189-112_2be8f6ba-3289-86ab-e063-6394a90acb89SPL ID 2be8f6ba-3289-86ab-e063-6394a90acb89SPL set ID a7e7c1ab-3e75-1ff8-e053-2995a90a7539RxCUI 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

N472189011230 followed by a unit qualifier and the quantity

Package 72189-0112-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Pantoprazole Sodium Delayed-Release Tablets are indicated for: 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 and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Panto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-112

What is NDC 72189-112?
72189-112 is the product NDC for Pantoprazole Sodium (pantoprazole), Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by DIRECT RX. It has 3 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?
DIRECT RX, NDC labeler code 72189. 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 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

Showing 20 of 35.

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