NDC 70518-2122

Isosorbide Mononitrate

Isosorbide Mononitrate

Isosorbide Mononitrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Isosorbide Mononitrate.

Product ID70518-2122_8a0cb178-d2cd-c2c7-e053-2a95a90a03cb
NDC70518-2122
Product TypeHuman Prescription Drug
Proprietary NameIsosorbide Mononitrate
Generic NameIsosorbide Mononitrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA075522
Labeler NameREMEDYREPACK INC.
Substance NameISOSORBIDE MONONITRATE
Active Ingredient Strength30 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2122-0

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2122-0)
Marketing Start Date2019-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2122-1 [70518212201]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075522
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 70518-2122-0 [70518212200]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075522
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-29

Drug Details

Active Ingredients

IngredientStrength
ISOSORBIDE MONONITRATE30 mg/1

OpenFDA Data

SPL SET ID:3c3699d1-b012-438b-8027-986962e318ac
Manufacturer
UNII

Pharmacological Class

  • Nitrate Vasodilator [EPC]
  • Nitrates [CS]
  • Vasodilation [PE]

NDC Crossover Matching brand name "Isosorbide Mononitrate" or generic name "Isosorbide Mononitrate"

NDCBrand NameGeneric Name
0143-1333Isosorbide MononitrateIsosorbide Mononitrate
0228-2620Isosorbide MononitrateIsosorbide Mononitrate
0228-2631Isosorbide MononitrateIsosorbide Mononitrate
0603-4110Isosorbide MononitrateIsosorbide Mononitrate
0603-4111Isosorbide MononitrateIsosorbide Mononitrate
0603-4112Isosorbide MononitrateIsosorbide Mononitrate
0615-4544Isosorbide MononitrateIsosorbide mononitrate
0615-4546Isosorbide MononitrateIsosorbide mononitrate
0615-5549Isosorbide MononitrateIsosorbide Mononitrate
0615-5550Isosorbide MononitrateIsosorbide Mononitrate
0615-7756Isosorbide MononitrateIsosorbide Mononitrate
0615-7757Isosorbide MononitrateIsosorbide Mononitrate
0615-7767ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
0615-7768ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
0615-8043ISOSORBIDE MONONITRATEisosorbide mononitrate
0615-8044ISOSORBIDE MONONITRATEisosorbide mononitrate
0904-6449ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
0904-6450ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
0904-6451ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
10544-243ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
13668-104ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
68071-1953Isosorbide MononitrateIsosorbide Mononitrate
68071-1926isosorbide mononitrateisosorbide mononitrate
68071-3015ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
68071-3081Isosorbide MononitrateIsosorbide Mononitrate
68071-3296Isosorbide MononitrateIsosorbide Mononitrate
68071-3266isosorbide mononitrateisosorbide mononitrate
68071-4290Isosorbide MononitrateIsosorbide Mononitrate
68084-591isosorbide mononitrateisosorbide mononitrate
68084-592isosorbide mononitrateisosorbide mononitrate
68151-1420isosorbide mononitrateisosorbide mononitrate
68151-0314isosorbide mononitrateisosorbide mononitrate
68382-651ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
68382-650ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
68382-652ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
68788-6863isosorbide mononitrateisosorbide mononitrate
70518-0009isosorbide mononitrateisosorbide mononitrate
70518-0214ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
70518-1080ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
70518-1485Isosorbide MononitrateIsosorbide Mononitrate
70934-183Isosorbide MononitrateIsosorbide Mononitrate
71335-0037Isosorbide MononitrateIsosorbide Mononitrate
71335-0431Isosorbide MononitrateIsosorbide Mononitrate
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE
21695-575isosorbide mononitrateisosorbide mononitrate
21695-777isosorbide mononitrateisosorbide mononitrate
21695-837isosorbide mononitrateisosorbide mononitrate
23155-628Isosorbide MononitrateIsosorbide Mononitrate
23155-178Isosorbide MononitrateIsosorbide Mononitrate
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.