Isosorbide Mononitrate NDC 13668-106

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0106Add 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
13668-106-01	13668010601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-01)Marketed from Jun 3, 2011
13668-106-10	13668010610	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-10)Marketed from Jun 3, 2011

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 — 120 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200495
Marketing start: Jun 3, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 13668-106_34e0adcc-8899-4abb-bba4-6be95d0ce2ddSPL ID 34e0adcc-8899-4abb-bba4-6be95d0ce2ddSPL set ID 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3cRxCUI 311196, 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

N413668010601 followed by a unit qualifier and the quantity

Package 13668-0106-01. 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

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 60 mg/1	Tablet, Extended releaseOral	Major Pharmaceuticals	0904-6450
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7768