Prescription drug · ANDA

Pantoprazole Sodium (Pantoprazole) NDC 68788-8644

Pantoprazole sodium 40 mg/1 · Tablet, Delayed release · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8644Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8644Add 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
68788-8644-16878886440168788864401100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-1)Marketed from May 1, 2024
68788-8644-3687888644036878886440330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-3)Marketed from May 1, 2024
68788-8644-6687888644066878886440660 TABLET, DELAYED RELEASE in 1 CARTON (68788-8644-6)Marketed from May 1, 2024
68788-8644-86878886440868788864408120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-8)Marketed from May 1, 2024
68788-8644-9687888644096878886440990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-9)Marketed from May 1, 2024

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 — 40 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8644_b7c006b5-a176-4266-a076-e49595cc7266SPL ID b7c006b5-a176-4266-a076-e49595cc7266SPL set ID 5c14e2f3-625d-4089-a404-440b0ecf72e7RxCUI 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

N468788864401 followed by a unit qualifier and the quantity

Package 68788-8644-01. 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 68788-8644

What is NDC 68788-8644?
68788-8644 is the product NDC for Pantoprazole Sodium (pantoprazole), Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in