NDC 68001-375

Isosorbide

Isosorbide Dinitrate

Isosorbide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Isosorbide Dinitrate.

• Product ID: 68001-375_9498fa14-1614-4a8e-b872-41c11745b01e
• NDC: 68001-375
• Product Type: Human Prescription Drug
• Proprietary Name: Isosorbide
• Generic Name: Isosorbide Dinitrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088088
• Labeler Name: BluePoint Laboratories
• Substance Name: ISOSORBIDE DINITRATE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68001-375-00

100 TABLET in 1 BOTTLE, PLASTIC (68001-375-00)

• Marketing Start Date: 2018-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68001-375-00 [68001037500]

Isosorbide TABLET

• Marketing Category: ANDA
• Application Number: ANDA088088
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-30

Drug Details

Active Ingredients

Ingredient	Strength
ISOSORBIDE DINITRATE	20 mg/1

OpenFDA Data

• SPL SET ID: 9498fa14-1614-4a8e-b872-41c11745b01e
• Manufacturer:
  • BluePoint Laboratories
• UNII:
  • IA7306519N
• RxNorm Concept Unique ID - RxCUI:
  • 314055
  • 206842
  • 381056
• UPC Code:
  • 0368001374002
  • 0368001373005
  • 0368001375009

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-2230	Isosorbide	Isosorbide mononitrate
0143-2260	Isosorbide	Isosorbide mononitrate
68001-373	Isosorbide	Isosorbide
68001-375	Isosorbide	Isosorbide
68001-374	Isosorbide	Isosorbide
68071-4390	Isosorbide	Isosorbide
68071-4689	Isosorbide	Isosorbide
68151-1418	Isosorbide	Isosorbide
71335-0739	Isosorbide	Isosorbide
53808-0275	Isosorbide	Isosorbide
53808-0274	Isosorbide	Isosorbide
59115-129	Isosorbide	Isosorbide
59115-143	Isosorbide	Isosorbide
59115-130	Isosorbide	Isosorbide
0187-0152	Isordil	isosorbide dinitrate
0187-0192	Isordil	isosorbide dinitrate
0143-1765	Isosorbide Dinitrate	Isosorbide Dinitrate
0143-1767	Isosorbide Dinitrate	Isosorbide Dinitrate
0143-1769	Isosorbide Dinitrate	Isosorbide Dinitrate
0143-1771	Isosorbide Dinitrate	Isosorbide Dinitrate
0143-1772	Isosorbide Dinitrate	Isosorbide Dinitrate
0615-1560	Isosorbide Dinitrate	Isosorbide Dinitrate
0615-1575	Isosorbide Dinitrate	Isosorbide Dinitrate
0615-7584	Isosorbide Dinitrate	isosorbide dinitrate
0615-7902	Isosorbide Dinitrate	Isosorbide Dinitrate
0615-7903	Isosorbide Dinitrate	Isosorbide Dinitrate
0615-8157	Isosorbide Dinitrate	isosorbide dinitrate
0615-8193	Isosorbide Dinitrate	isosorbide dinitrate
0615-8294	Isosorbide Dinitrate	isosorbide dinitrate
0781-1556	Isosorbide Dinitrate	Isosorbide Dinitrate
0781-1635	Isosorbide Dinitrate	Isosorbide Dinitrate
0781-1695	Isosorbide Dinitrate	Isosorbide Dinitrate