What is NDC 43353-027?

43353-027 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-027 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-027Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0027Add 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
43353-027-30	4335300273043353002730	30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-30)Marketed from Apr 29, 2015
43353-027-53	4335300275343353002753	60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53)Marketed from Apr 29, 2015
43353-027-60	4335300276043353002760	90 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-60)Marketed from Apr 19, 2016
43353-027-80	4335300278043353002780	180 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-80)Marketed from Apr 19, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 40 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078281
Marketing start: Jan 20, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 43353-027_244f530f-f490-4ad9-ad20-bf541fb4f95fSPL ID 244f530f-f490-4ad9-ad20-bf541fb4f95fSPL set ID c9bc288b-e84c-4e31-a769-c87a59226086RxCUI 251872, 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

N443353002730 followed by a unit qualifier and the quantity

Package 43353-0027-30. 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 9, 2025.

Indications (excerpt from the label)

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole 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 Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole is 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 erosive esophagitis (EE). For those …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-027

What is NDC 43353-027?: 43353-027 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 078281

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

FDA NDC Directory listings under ANDA 078281
Product	Strength	Form · route	Labeler	Product NDC
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	AvPAK	50268-585
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	AvPAK	50268-639
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Golden State Medical Supply, Inc.	51407-612
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Golden State Medical Supply, Inc.	51407-613
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-4346
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Chartwell RX, LLC	62135-533
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Chartwell RX, LLC	62135-534
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Lannett Company, Inc.	62175-617
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Lannett Company, Inc.	62175-618
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	63187-938
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	72162-1746
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-086