Isosorbide Mononitrate NDC 62559-252

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-252Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0252Add 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
62559-252-01	62559025201	100 TABLET in 1 BOTTLE (62559-252-01)Marketed from Mar 27, 2026

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: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075147
Marketing start: Mar 27, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 62559-252_616fb1d3-ab4c-40a1-b11a-7a913f0b617cSPL ID 616fb1d3-ab4c-40a1-b11a-7a913f0b617cSPL set ID 06839534-85b8-42aa-b0e3-079ed236be44RxCUI 311192, 311197UNII LX1OH63030UPC 0362559252010, 0362559253017
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

N462559025201 followed by a unit qualifier and the quantity

Package 62559-0252-01. 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 Mar 27, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isosorbide Mononitrate Tablets USP 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 ANDA 075147

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

FDA NDC Directory listings under ANDA 075147
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-253
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Coupler LLC	67046-1687