What is NDC 0338-9644?

0338-9644 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/100mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Pantoprazole Sodium (Pantoprazole Sodium in 0.9% Sodium Chloride).

Baxter Healthcare Company, NDC labeler code 0338. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pantoprazole Sodium NDC 0338-9644 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9644Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9644Add 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 NDC	11-digit (billing)	Package	Copy
0338-9644-12	0033896441200338964412	12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01)Marketed from Feb 14, 2024

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): Pantoprazole Sodium
Generic name (nonproprietary): pantoprazole sodium in 0.9% sodium chloride
Active ingredients: Pantoprazole sodium — 40 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Baxter Healthcare CompanyNDC labeler code 0338
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217512
Marketing start: Feb 14, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0338-9644_38f70f97-5429-45e4-ad5f-da4c1e2c6233SPL ID 38f70f97-5429-45e4-ad5f-da4c1e2c6233SPL set ID a476e063-9450-4793-9a22-16b0a0a61cd0RxCUI 2675781, 2675784, 2675786UNII 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

N400338964412 followed by a unit qualifier and the quantity

Package 00338-9644-12. 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 Feb 14, 2024.

Indications (excerpt from the label)

Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. ( 1.2 ) 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-9644

What is NDC 0338-9644?: 0338-9644 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/100mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pantoprazole Sodium (Pantoprazole Sodium in 0.9% Sodium Chloride).
What is the active ingredient?: Pantoprazole sodium.
Who is the labeler?: Baxter Healthcare Company, NDC labeler code 0338. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pantoprazole Sodium	Pantoprazole sodium 40 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Avenacy, LLC	83634-751	83634-0751-10
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-0289	55154-0289-00
Pantoprazole Sodiumpantoprazole	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	AvPAK	50268-727	50268-0727-10
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-066	87441-0066-01
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-065	87441-0065-01
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-0347	67046-0347-03
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-0536	67046-0536-03
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Safecor Health LLC	48433-081	48433-0081-20
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	NorthStar Rx LLC	72603-746	72603-0746-0172603-0746-02
Pantoprazole Sodium	Pantoprazole sodium 40 mg/10mL	Injection, Powder, For solutionIntravenous	Devatis Inc.	73043-020	73043-0020-0173043-0020-1073043-0020-25

All 136 Pantoprazole Sodium NDCs

Other NDCs under NDA 217512

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

FDA NDC Directory listings under NDA 217512
Product	Strength	Form · route	Labeler	Product NDC
Pantoprazole Sodiumpantoprazole sodium in 0.9% sodium chloride	Pantoprazole sodium 40 mg/50mL	Injection, SolutionIntravenous	Baxter Healthcare Company	0338-9646
Pantoprazole Sodiumpantoprazole sodium in 0.9% sodium chloride	Pantoprazole sodium 80 mg/100mL	Injection, SolutionIntravenous	Baxter Healthcare Company	0338-9648