What is NDC 0228-2620?

0228-2620 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 20 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Isosorbide Mononitrate?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Isosorbide Mononitrate NDC 0228-2620

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-2620Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-2620Add 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
0228-2620-11	0022826201100228262011	100 TABLET in 1 BOTTLE (0228-2620-11)Marketed from Oct 30, 1998

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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075037
Marketing start: Oct 30, 1998
Marketing end: Apr 30, 2027
Other FDA classes: Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers: Product ID 0228-2620_1cb05f66-1c19-4300-8745-8c74c1dccb2bSPL ID 1cb05f66-1c19-4300-8745-8c74c1dccb2bSPL set ID ae8f74f0-e600-4452-8557-958b603e2709RxCUI 311192, 311197UNII LX1OH63030UPC 0302282631119, 0302282620113
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

N400228262011 followed by a unit qualifier and the quantity

Package 00228-2620-11. 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 Oct 1, 2022.

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)

About NDC 0228-2620

What is NDC 0228-2620?: 0228-2620 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 20 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Isosorbide Mononitrate.
What is the active ingredient?: Isosorbide mononitrate.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Isosorbide Mononitrate?: 61 other product NDCs are listed under this name. See all Isosorbide Mononitrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Isosorbide Mononitrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Isosorbide Mononitrate	Isosorbide mononitrate 120 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-161	11788-0161-01
Isosorbide Mononitrate	Isosorbide mononitrate 30 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-159	11788-0159-0111788-0159-0511788-0159-10
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	AiPing Pharmaceutical, Inc.	11788-160	11788-0160-0111788-0160-0511788-0160-10
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Coupler LLC	67046-1687	67046-1687-03
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Genus Lifesciences Inc.	64950-251	64950-0251-01
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Genus Lifesciences Inc.	64950-250	64950-0250-01
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-252	62559-0252-01
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-253	62559-0253-01
Isosorbide Mononitrate	Isosorbide mononitrate 60 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1632	67046-1632-03
isosorbide mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Coupler LLC	67046-1578	67046-1578-03

All 62 Isosorbide Mononitrate NDCs

Other NDCs under ANDA 075037

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

FDA NDC Directory listings under ANDA 075037
Product	Strength	Form · route	Labeler	Product NDC
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Actavis Pharma, Inc.	0228-2631
Isosorbide Mononitrate	Isosorbide mononitrate 10 mg/1	TabletOral	Genus Lifesciences Inc.	64950-250
Isosorbide Mononitrate	Isosorbide mononitrate 20 mg/1	TabletOral	Genus Lifesciences Inc.	64950-251