NDC 23155-628

Isosorbide Mononitrate

Isosorbide Mononitrate

Isosorbide Mononitrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The primary component is Isosorbide Mononitrate.

• Product ID: 23155-628_649023db-b51a-4696-ae92-28c926efc2d6
• NDC: 23155-628
• Product Type: Human Prescription Drug
• Proprietary Name: Isosorbide Mononitrate
• Generic Name: Isosorbide Mononitrate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210822
• Labeler Name: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
• Substance Name: ISOSORBIDE MONONITRATE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 23155-628-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-628-01)

• Marketing Start Date: 2018-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 23155-628-01 [23155062801]

Isosorbide Mononitrate TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA210822
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-15

Drug Details

Active Ingredients

Ingredient	Strength
ISOSORBIDE MONONITRATE	120 mg/1

OpenFDA Data

• SPL SET ID: 22ee5b6a-f241-43e7-94da-18dc1aafcfe9
• Manufacturer:
  • Heritage Pharmaceuticals, Inc.
• UNII:
  • LX1OH63030
• RxNorm Concept Unique ID - RxCUI:
  • 311196
• UPC Code:
  • 0323155628012

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-1333	Isosorbide Mononitrate	Isosorbide Mononitrate
0228-2620	Isosorbide Mononitrate	Isosorbide Mononitrate
0228-2631	Isosorbide Mononitrate	Isosorbide Mononitrate
0603-4110	Isosorbide Mononitrate	Isosorbide Mononitrate
0603-4111	Isosorbide Mononitrate	Isosorbide Mononitrate
0603-4112	Isosorbide Mononitrate	Isosorbide Mononitrate
0615-4544	Isosorbide Mononitrate	Isosorbide mononitrate
0615-4546	Isosorbide Mononitrate	Isosorbide mononitrate
0615-5549	Isosorbide Mononitrate	Isosorbide Mononitrate
0615-5550	Isosorbide Mononitrate	Isosorbide Mononitrate
0615-7756	Isosorbide Mononitrate	Isosorbide Mononitrate
0615-7757	Isosorbide Mononitrate	Isosorbide Mononitrate
0615-7767	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
0615-7768	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
0615-8043	ISOSORBIDE MONONITRATE	isosorbide mononitrate
0615-8044	ISOSORBIDE MONONITRATE	isosorbide mononitrate
0904-6449	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
0904-6450	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
0904-6451	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
10544-243	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
13668-104	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
68071-1953	Isosorbide Mononitrate	Isosorbide Mononitrate
68071-1926	isosorbide mononitrate	isosorbide mononitrate
68071-3015	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
68071-3081	Isosorbide Mononitrate	Isosorbide Mononitrate
68071-3296	Isosorbide Mononitrate	Isosorbide Mononitrate
68071-3266	isosorbide mononitrate	isosorbide mononitrate
68071-4290	Isosorbide Mononitrate	Isosorbide Mononitrate
68084-591	isosorbide mononitrate	isosorbide mononitrate
68084-592	isosorbide mononitrate	isosorbide mononitrate
68151-1420	isosorbide mononitrate	isosorbide mononitrate
68151-0314	isosorbide mononitrate	isosorbide mononitrate
68382-651	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
68382-650	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
68382-652	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
68788-6863	isosorbide mononitrate	isosorbide mononitrate
70518-0009	isosorbide mononitrate	isosorbide mononitrate
70518-0214	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
70518-1080	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate
70934-183	Isosorbide Mononitrate	Isosorbide Mononitrate
71335-0037	Isosorbide Mononitrate	Isosorbide Mononitrate
71335-0431	Isosorbide Mononitrate	Isosorbide Mononitrate
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE
21695-575	isosorbide mononitrate	isosorbide mononitrate
21695-777	isosorbide mononitrate	isosorbide mononitrate
21695-837	isosorbide mononitrate	isosorbide mononitrate
23155-628	Isosorbide Mononitrate	Isosorbide Mononitrate
23155-178	Isosorbide Mononitrate	Isosorbide Mononitrate