NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8505Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8505Add 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
68788-8505-16878885050168788850501100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-1)Marketed from Aug 15, 2023
68788-8505-3687888505036878885050330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-3)Marketed from Aug 15, 2023
68788-8505-6687888505066878885050660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-6)Marketed from Aug 15, 2023
68788-8505-86878885050868788850508120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-8)Marketed from Aug 15, 2023
68788-8505-9687888505096878885050990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-9)Marketed from Aug 15, 2023

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
Generic name (nonproprietary)
pantoprazole
Active ingredients
Pantoprazole sodium — 20 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 077619
Marketing start
Listing expires
Other FDA classes
Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 68788-8505_1af41671-2900-4e22-acfd-40459390e9c1SPL ID 1af41671-2900-4e22-acfd-40459390e9c1SPL set ID bb1e79ad-ff52-4696-8743-523f793b29d3RxCUI 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

N468788850501 followed by a unit qualifier and the quantity

Package 68788-8505-01. 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 is a proton pump inhibitor (PPI) indicated for the following: 1. Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) () 2. Maintenance of Healing of Erosive Esophagitis () 3. Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome () 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 healing and symptomatic relief of ero…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8505

What is NDC 68788-8505?
68788-8505 is the product NDC for Pantoprazole, Pantoprazole sodium 20 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.
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?
11 other product NDCs are listed under this name. See all Pantoprazole 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralCoupler LLC67046-078967046-0789-03
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-055280425-0552-0180425-0552-0280425-0552-03
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-377668071-3776-0368071-3776-06
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-399568071-3995-09
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNorthStar RxLLC72603-17772603-0177-01
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNorthStar RxLLC72603-17872603-0178-01
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-57460760-0574-3060760-0574-60
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-33255111-0332-0155111-0332-0555111-0332-10+4 more
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-33355111-0333-0155111-0333-0555111-0333-10+4 more
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-352468071-3524-03

All 12 Pantoprazole NDCs

Other NDCs under ANDA 077619

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

FDA NDC Directory listings under ANDA 077619
ProductStrengthForm · routeLabelerProduct NDC
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralCoupler LLC67046-0789
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-332
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralDr.Reddy's Laboratories Limited55111-333
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3995
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0552
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3524
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3776
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-574
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralRedpharm Drug67296-2355
PantoprazolePantoprazole sodium 40 mg/1Tablet, Delayed releaseOralNorthStar RxLLC72603-178
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralNorthStar RxLLC72603-177
PantoprazolePantoprazole sodium 20 mg/1Tablet, Delayed releaseOralPHOENIX RX LLC85509-1332

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