NDC codes

FDA NDC Directory
Product NDC (as listed)0008-4001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00008-4001Add 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
0008-4001-100000840011010 CARTON in 1 PACKAGE (0008-4001-10) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIALMarketed from May 1, 2013
0008-4001-250000840012525 CARTON in 1 PACKAGE (0008-4001-25) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIALMarketed from May 1, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Protonix I.V.Suffix: I.V.
Generic name (nonproprietary)
pantoprazole sodium
Active ingredients
Pantoprazole sodium40 mg/10mL
Dosage form
Injection, Powder, For solution
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020988
Marketing start
Listing expires
Other FDA classes
Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 0008-4001_d36cd2fb-517f-44e5-8438-53e563775f86SPL ID d36cd2fb-517f-44e5-8438-53e563775f86SPL set ID f39b3e7d-39d2-4c8a-9974-4ab885241880RxCUI 283669, 885257UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400008400110 followed by a unit qualifier and the quantity

Package 00008-4001-10. 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)

PROTONIX I.V. is indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatric patients 3 months and older . • pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of PROTONIX I.V. for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. PROTONIX I.V. is a proton pump inhibitor (PPI) indicated for treatment of: • gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults and up to 7 days in pediatri

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020988

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

FDA NDC Directory listings under NDA 020988
ProductStrengthForm · routeLabelerProduct NDC
Protonix I.V.pantoprazole sodiumPantoprazole sodium 40 mg/10mLInjection, Powder, For solutionIntravenousCardinal Health 107, LLC55154-4236
Protonix I.V.pantoprazole sodiumPantoprazole sodium 40 mg/10mLInjection, Powder, For solutionIntravenousCardinal Health 107, LLC55154-4225
Protonix I.V.pantoprazole sodiumPantoprazole sodium 40 mg/10mLInjection, Powder, For solutionIntravenousWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0008-0923

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