NDC 0023-5853

Delzicol

Mesalamine

Delzicol is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Mesalamine.

• Product ID: 0023-5853_1534833e-8b46-4073-8283-ef9114224665
• NDC: 0023-5853
• Product Type: Human Prescription Drug
• Proprietary Name: Delzicol
• Generic Name: Mesalamine
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-16
• Marketing Category: NDA / NDA
• Application Number: NDA204412
• Labeler Name: Allergan, Inc.
• Substance Name: MESALAMINE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0023-5853-18

180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0023-5853-18)

• Marketing Start Date: 2016-05-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-5853-12 [00023585312]

Delzicol CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA204412
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-16
• Marketing End Date: 2017-08-02

NDC 0023-5853-00 [00023585300]

Delzicol CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA204412
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-16
• Marketing End Date: 2019-01-18

NDC 0023-5853-18 [00023585318]

Delzicol CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA204412
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-16

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	400 mg/1

OpenFDA Data

• SPL SET ID: 71b02324-9430-4269-825f-8fcac5eeaefb
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 1368954
  • 1368960
• UPC Code:
  • 0300235853182

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

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

NDC	Brand Name	Generic Name
0023-5853	Delzicol	mesalamine
68151-5652	Delzicol	Delzicol
50090-3002	Delzicol	Delzicol
0023-5901	Asacol HD	mesalamine
0430-0783	ASACOL HD	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