isosorbide mononitrate NDC 62175-106

NDC codes

FDA NDC Directory

Product NDC (as listed)62175-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62175-0106Add 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
62175-106-01	62175010601	100 TABLET in 1 BOTTLE (62175-106-01)Marketed from Jun 30, 1993

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): isosorbide mononitrate
Generic name (nonproprietary): isosorbide mononitrate
Active ingredients: Isosorbide mononitrate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lannett Company, Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020215
Marketing start: Jun 30, 1993
Listing expires: Dec 31, 2026
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 62175-106_81e3e7e0-b677-4948-9e04-6c3a44ea313bSPL ID 81e3e7e0-b677-4948-9e04-6c3a44ea313bSPL set ID bf9e7e35-7707-42a0-88d6-6292fa52bbfaRxCUI 311192, 311197UNII LX1OH63030UPC 0362175107015, 0362175106018
Pharmacologic class: Nitrate Vasodilator

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

N462175010601 followed by a unit qualifier and the quantity

Package 62175-0106-01. 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 5, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020215

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

FDA NDC Directory listings under NDA 020215
Product	Strength	Form · route	Labeler	Product NDC
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Proficient Rx LP	63187-900
isosorbide mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Coupler LLC	67046-1577
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Coupler LLC	67046-1578
isosorbide mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	OMNIVIUM PHARMACEUTICALS LLC.	81665-102
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	OMNIVIUM PHARMACEUTICALS LLC.	81665-103
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Lannett Company, Inc.	62175-107