NDC codes

FDA NDC Directory
Product NDC (as listed)64950-251Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64950-0251Add 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 NDC11-digit (billing)PackageCopy
64950-251-016495002510164950025101100 TABLET in 1 BOTTLE (64950-251-01)Marketed from Apr 9, 2026

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 — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Genus Lifesciences Inc.NDC labeler code 64950
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075037
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 64950-251_74da603c-8c7e-4823-a2a7-82e6ae007531SPL ID 74da603c-8c7e-4823-a2a7-82e6ae007531SPL set ID 0d739bf3-0672-4504-9064-b39d6b200b47RxCUI 311192, 311197UNII LX1OH63030UPC 0364950250015, 0364950251012
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

N464950025101 followed by a unit qualifier and the quantity

Package 64950-0251-01. 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 .

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 64950-251

What is NDC 64950-251?
64950-251 is the product NDC for Isosorbide Mononitrate, Isosorbide mononitrate 20 mg/1 tablet, listed with the FDA by Genus Lifesciences 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?
Genus Lifesciences Inc., NDC labeler code 64950. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-16111788-0161-01
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-15911788-0159-0111788-0159-0511788-0159-10
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralAiPing Pharmaceutical, Inc.11788-16011788-0160-0111788-0160-0511788-0160-10
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralCoupler LLC67046-168767046-1687-03
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralGenus Lifesciences Inc.64950-25064950-0250-01
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralANI Pharmaceuticals, Inc.62559-25262559-0252-01
Isosorbide MononitrateIsosorbide mononitrate 20 mg/1TabletOralANI Pharmaceuticals, Inc.62559-25362559-0253-01
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralCoupler LLC67046-163267046-1632-03
isosorbide mononitrateIsosorbide mononitrate 20 mg/1TabletOralCoupler LLC67046-157867046-1578-03
isosorbide mononitrateIsosorbide mononitrate 10 mg/1TabletOralCoupler LLC67046-157767046-1577-03

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
ProductStrengthForm · routeLabelerProduct NDC
Isosorbide MononitrateIsosorbide mononitrate 20 mg/1TabletOralActavis Pharma, Inc.0228-2620
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralActavis Pharma, Inc.0228-2631
Isosorbide MononitrateIsosorbide mononitrate 10 mg/1TabletOralGenus Lifesciences Inc.64950-250

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