What is NDC 0378-6689?

0378-6689 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-6689 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6689Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6689Add 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
0378-6689-10	0037866891000378668910	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10)Marketed from Jan 19, 2011
0378-6689-77	0037866897700378668977	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-77)Marketed from Jan 19, 2011

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 — 40 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090970
Marketing start: Jan 19, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0378-6689_38896560-f523-4d0b-8113-5ff7f5f38c81SPL ID 38896560-f523-4d0b-8113-5ff7f5f38c81SPL set ID 56ad5b97-8e5f-48a5-b2ba-a5484b43d018RxCUI 251872, 314200UNII 6871619Q5XUPC 0303786689774, 0303786688777
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

N400378668910 followed by a unit qualifier and the quantity

Package 00378-6689-10. 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 Aug 15, 2023.

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-6689

What is NDC 0378-6689?: 0378-6689 is the product NDC for Pantoprazole Sodium, Pantoprazole sodium 40 mg/1 tablet, delayed release, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 090970

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

FDA NDC Directory listings under ANDA 090970
Product	Strength	Form · route	Labeler	Product NDC
Pantoprazole Sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Mylan Pharmaceuticals Inc.	0378-6688
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7629
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	QPharma Inc	42708-180
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Safecor Health LLC	48433-081
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Mylan Institutional Inc.	51079-051
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-0289
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Cardinal Health 107, LLC	55154-4382
Pantoprazole Sodium	Pantoprazole sodium 40 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-1429
Pantoprazole Sodium DRpantoprazole sodium	Pantoprazole sodium 20 mg/1	Tablet, Delayed releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0179