NDC codes

FDA NDC Directory
Product NDC (as listed)50268-585Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0585Add 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
50268-585-15502680585155026805851550 BLISTER PACK in 1 BOX (50268-585-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)Marketed from Jan 28, 2021

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 sodium
Active ingredients
Pantoprazole sodium — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078281
Marketing start
Listing expires
Other FDA classes
Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 50268-585_4510e1ae-df21-156c-e063-6394a90a09daSPL ID 4510e1ae-df21-156c-e063-6394a90a09daSPL set ID b9fa8381-b75e-b1cd-e053-2a95a90a9883RxCUI 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

N450268058515 followed by a unit qualifier and the quantity

Package 50268-0585-15. 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, USP are indicated for: Pantoprazole 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 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-585

What is NDC 50268-585?
50268-585 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pantoprazole Sodium.
What is the active ingredient?
Pantoprazole sodium.
Who is the labeler?
AvPAK, NDC labeler code 50268. 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 078281

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

FDA NDC Directory listings under ANDA 078281
ProductStrengthForm · routeLabelerProduct NDC
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC43353-027
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralAvPAK50268-639
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-612
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-613
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralCardinal Health 107, LLC55154-4346
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralChartwell RX, LLC62135-533
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralChartwell RX, LLC62135-534
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralLannett Company, Inc.62175-617
Pantoprazole SodiumPantoprazole sodium 20 mg/1Tablet, Delayed releaseOralLannett Company, Inc.62175-618
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-938
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack72162-1746
Pantoprazole SodiumPantoprazole sodium 40 mg/1Tablet, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-086

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