NDC 53808-0823

ASACOL

Mesalamine

ASACOL is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Mesalamine.

• Product ID: 53808-0823_51806be1-d5f5-4a7c-afba-12ebd6234980
• NDC: 53808-0823
• Product Type: Human Prescription Drug
• Proprietary Name: ASACOL
• Generic Name: Mesalamine
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA019651
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: MESALAMINE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53808-0823-1

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-0823-1)

• Marketing Start Date: 2013-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0823-1 [53808082301]

ASACOL TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA019651
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	400 mg/1

OpenFDA Data

• SPL SET ID: a97c3815-a0d5-4763-8c3f-9caa5dd9b01b
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 311550
  • 104112

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

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

NDC	Brand Name	Generic Name
53808-0205	Asacol	Asacol
53808-0823	ASACOL	ASACOL
55154-2305	Asacol	Asacol
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