What is NDC 0615-8113?

0615-8113 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8113 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8113Add 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
0615-8113-05	0061581130500615811305	15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-05)Marketed from Dec 15, 2022
0615-8113-39	0061581133900615811339	30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8113-39)Marketed from Nov 7, 2018

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
Active ingredients: Pantoprazole sodium — 20 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202038
Marketing start: Sep 28, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0615-8113_ee95d143-2812-493e-85ec-1dd0deb22990SPL ID ee95d143-2812-493e-85ec-1dd0deb22990SPL set ID 1680b4ed-d5b0-4fd9-b1d1-04df6a2138beRxCUI 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

N400615811305 followed by a unit qualifier and the quantity

Package 00615-8113-05. 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 Jun 12, 2024.

Indications (excerpt from the label)

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are 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 healing and …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8113

What is NDC 0615-8113?: 0615-8113 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 ANDA 202038

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

FDA NDC Directory listings under ANDA 202038
Product	Strength	Form · route	Labeler	Product NDC
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-7458
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-725
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-4895
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Aurobindo Pharma Limited	65862-560
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-805
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-806
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	51655-797
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-1165
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Redpharm Drug	67296-1812
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-6870
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-1788
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-5361
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-5379
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	HAWAII REPACK, INC.	85534-0027
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-5378
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-5053
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-2645
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	HAWAII REPACK, INC.	85534-0061
Pantoprazole Sodium DRpantoprazole sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Advanced Rx of Tennessee, LLC	80425-0406
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-736

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