NDC 65084-474

Canasa

Mesalamine

Canasa is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Mckesson Rxpak Inc. The primary component is Mesalamine.

• Product ID: 65084-474_f22429d1-5a9e-4286-a856-8104e188e35e
• NDC: 65084-474
• Product Type: Human Prescription Drug
• Proprietary Name: Canasa
• Generic Name: Mesalamine
• Dosage Form: Suppository
• Route of Administration: RECTAL
• Marketing Start Date: 2001-01-05
• Marketing Category: NDA / NDA
• Application Number: NDA021252
• Labeler Name: Mckesson Rxpak Inc
• Substance Name: MESALAMINE
• Active Ingredient Strength: 1000 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65084-474-14

30 SUPPOSITORY in 1 BOX (65084-474-14)

• Marketing Start Date: 2016-01-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65084-474-14 [65084047414]

Canasa SUPPOSITORY

• Marketing Category: NDA
• Application Number: NDA021252
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-20
• Marketing End Date: 2019-09-01

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	1000 mg/1

OpenFDA Data

• SPL SET ID: 75fb1efa-d513-4203-8962-6508a24ef3eb
• Manufacturer:
  • Mckesson Rxpak Inc
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 583257
  • 248420

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

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

NDC	Brand Name	Generic Name
58914-501	Canasa	Canasa
65084-474	Canasa	Canasa
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