NDC 69189-0189

Pentasa

Mesalamine

Pentasa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Mesalamine.

• Product ID: 69189-0189_6618dfe2-5b3c-4357-a0bf-b58901cd367b
• NDC: 69189-0189
• Product Type: Human Prescription Drug
• Proprietary Name: Pentasa
• Generic Name: Mesalamine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-04-27
• Marketing Category: NDA / NDA
• Application Number: NDA020049
• Labeler Name: Avera McKennan Hospital
• Substance Name: MESALAMINE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69189-0189-1

1 CAPSULE in 1 DOSE PACK (69189-0189-1)

• Marketing Start Date: 2015-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-0189-1 [69189018901]

Pentasa CAPSULE

• Marketing Category: NDA
• Application Number: NDA020049
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-04-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	250 mg/1

OpenFDA Data

• SPL SET ID: 3a4dbb01-3c0f-4217-8e33-e37263878828
• Manufacturer:
  • Avera McKennan Hospital
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 314092
  • 206791

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

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