Prescription drug · ANDA

Isosorbide Mononitrate NDC 51407-209

Isosorbide mononitrate 60 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51407-209Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0209Add 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
51407-209-0151407020901100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-209-01)Marketed from Apr 19, 2019
51407-209-0551407020905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-209-05)Marketed from Apr 19, 2019

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210918
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 51407-209_26ab803d-04f8-b766-e063-6394a90a117fSPL ID 26ab803d-04f8-b766-e063-6394a90a117fSPL set ID 86be0e85-5337-bee4-e053-2a91aa0a8158RxCUI 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

N451407020901 followed by a unit qualifier and the quantity

Package 51407-0209-01. 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 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 210918

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

FDA NDC Directory listings under ANDA 210918
ProductStrengthForm · routeLabelerProduct NDC
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-922
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-175
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-176
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-177
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-772
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7038
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-788
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-208
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-825
Isosorbide MononitrateIsosorbide mononitrate 120 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-210
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2194
Isosorbide MononitrateIsosorbide mononitrate 60 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2192
Isosorbide MononitrateIsosorbide mononitrate 30 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5686

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Isosorbide Mononitrate NDC 51407-209 | Med-Code