NDC 43353-884

APRISO

Mesalamine

APRISO is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Mesalamine.

• Product ID: 43353-884_08025228-3c71-400b-95ff-80d6aea38f33
• NDC: 43353-884
• Product Type: Human Prescription Drug
• Proprietary Name: APRISO
• Generic Name: Mesalamine
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-10-31
• Marketing Category: NDA / NDA
• Application Number: NDA022301
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: MESALAMINE
• Active Ingredient Strength: 375 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-884-79

2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79)

• Marketing Start Date: 2014-02-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-884-79 [43353088479]

APRISO CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022301
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-02-17

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	375 mg/1

OpenFDA Data

• SPL SET ID: faaaa4b7-087e-4c50-820d-561f8f39adc8
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 825134
  • 825130

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]
• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

NDC Crossover Matching brand name "APRISO" or generic name "Mesalamine"

NDC	Brand Name	Generic Name
43353-884	APRISO	APRISO
65649-103	APRISO	APRISO
0023-5901	Asacol HD	mesalamine
0430-0783	ASACOL HD	mesalamine
0023-5853	Delzicol	mesalamine
0179-0142	Lialda	mesalamine
0093-5907	Mesalamine	Mesalamine
0093-9224	mesalamine	mesalamine
0378-1375	Mesalamine	mesalamine
0378-9230	Mesalamine	mesalamine
0472-1915	Mesalamine	Mesalamine
0037-0066	Rowasa	mesalamine
0037-0022	sfRowasa	mesalamine