Isosorbide Mononitrate NDC 42677-306

NDC codes

FDA NDC Directory

Product NDC (as listed)42677-306Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42677-0306Add 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
42677-306-01	42677030601	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42677-306-01)Marketed from Feb 8, 2024

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 — 60 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Shandong New Time Pharmaceutical Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214115
Marketing start: Feb 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 42677-306_47b286d2-bbaf-75ff-e063-6294a90a6de7SPL ID 47b286d2-bbaf-75ff-e063-6294a90a6de7SPL set ID cd953cfa-b6f5-4b82-afcc-52a57236b9d3RxCUI 311196, 317110, 353538UNII LX1OH63030UPC 0342677306017, 0342677307021, 0342677307014, 0342677305010
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

N442677030601 followed by a unit qualifier and the quantity

Package 42677-0306-01. 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 Jan 6, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Isosorbide mononitrate extended-release tablets are indicated for the prevention 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 214115

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

FDA NDC Directory listings under ANDA 214115
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-305
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-307