NDC 53808-0205

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: 53808-0205_bac1e923-6161-462a-bfd3-37cfb34a7313
• NDC: 53808-0205
• Product Type: Human Prescription Drug
• Proprietary Name: Asacol
• Generic Name: Mesalamine
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53808-0205-1

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-0205-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0205-1 [53808020501]

Asacol TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA019651
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	400 mg/1

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