Isosorbide Mononitrate NDC 0904-6450

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6450Add 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
0904-6450-61	00904645061	100 BLISTER PACK in 1 CARTON (0904-6450-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 5, 2015

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): Isosorbide Mononitrate
Generic name (nonproprietary): isosorbide mononitrate
Active ingredients: Isosorbide mononitrate — 60 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200495
Marketing start: Jan 5, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 0904-6450_228e57f0-57e5-4305-802a-0b87fb9b4c68SPL ID 228e57f0-57e5-4305-802a-0b87fb9b4c68SPL set ID 8cbb364a-bafe-454b-a53f-bd7cd69a5593RxCUI 317110, 353538UNII LX1OH63030
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

N400904645061 followed by a unit qualifier and the quantity

Package 00904-6450-61. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 200495

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

FDA NDC Directory listings under ANDA 200495
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-794
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Cardinal Health 107, LLC	55154-7292
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Torrent Pharmaceuticals Limited	13668-105
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	Torrent Pharmaceuticals Limited	13668-106
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7768