NDC 54092-191

Pentasa

Mesalamine

Pentasa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Mesalamine.

• Product ID: 54092-191_642f21aa-73bf-4414-afb7-e29c879c1600
• NDC: 54092-191
• Product Type: Human Prescription Drug
• Proprietary Name: Pentasa
• Generic Name: Mesalamine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2004-07-08
• Marketing Category: NDA / NDA
• Application Number: NDA020049
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: MESALAMINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 54092-191-12

120 CAPSULE in 1 BOTTLE (54092-191-12)

• Marketing Start Date: 2004-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-191-08 [54092019108]

Pentasa CAPSULE

• Marketing Category: NDA
• Application Number: NDA020049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-07-08

NDC 54092-191-12 [54092019112]

Pentasa CAPSULE

• Marketing Category: NDA
• Application Number: NDA020049
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-08

NDC 54092-191-80 [54092019180]

Pentasa CAPSULE

• Marketing Category: NDA
• Application Number: NDA020049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-07-08
• Marketing End Date: 2010-03-17

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	500 mg/1

OpenFDA Data

• SPL SET ID: e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 476362
  • 314092
  • 580286
  • 206791

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

Medicade Reported Pricing

54092019112 PENTASA 500 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
68151-4769	Pentasa	Pentasa
69189-0189	Pentasa	Pentasa
54092-189	Pentasa	Pentasa
54092-191	Pentasa	Pentasa
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