Isosorbide Dinitrate NDC 50268-448

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0448Add 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
50268-448-15	50268044815	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-448-15) / 1 TABLET in 1 BLISTER PACK (50268-448-11)Marketed from Jun 6, 2017

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 Dinitrate
Generic name (nonproprietary): isosorbide dinitrate
Active ingredients: Isosorbide dinitrate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 086925
Marketing start: Jun 6, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 50268-448_4a7f77ca-73e0-4162-e063-6294a90a1418SPL ID 4a7f77ca-73e0-4162-e063-6294a90a1418SPL set ID 0e5842f2-74f6-1f02-01bc-07578bd3b393RxCUI 206842, 314055, 381056UNII IA7306519N
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

N450268044815 followed by a unit qualifier and the quantity

Package 50268-0448-15. 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 Feb 10, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate 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 086925

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

FDA NDC Directory listings under ANDA 086925
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	Par Health USA, LLC	49884-021
Isosorbide Dinitrate	Isosorbide dinitrate 10 mg/1	TabletOral	American Health Packaging	68084-082