NDC 54092-476

Lialda

Mesalamine

Lialda is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Mesalamine.

• Product ID: 54092-476_0fe0314c-771b-45d5-ac5b-9879eb121aba
• NDC: 54092-476
• Product Type: Human Prescription Drug
• Proprietary Name: Lialda
• Generic Name: Mesalamine
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2007-01-16
• Marketing Category: NDA / NDA
• Application Number: NDA022000
• Labeler Name: Shire US Manufacturing Inc.
• Substance Name: MESALAMINE
• Active Ingredient Strength: 1 g/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54092-476-01

120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)

• Marketing Start Date: 2007-01-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-476-02 [54092047602]

Lialda TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-16

NDC 54092-476-08 [54092047608]

Lialda TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022000
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-01-16

NDC 54092-476-12 [54092047612]

Lialda TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-16

NDC 54092-476-01 [54092047601]

Lialda TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-16

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	1.2 g/1

OpenFDA Data

• SPL SET ID: 3098a080-be86-4265-9818-7fc4beab77b7
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 686433
  • 686429
• UPC Code:
  • 0354092476015

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

Medicade Reported Pricing

54092047612 LIALDA DR 1.2 GM TABLET

Pricing Unit: EA | Drug Type:

54092047602 LIALDA DR 1.2 GM TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
0179-0142	Lialda	mesalamine
54092-476	Lialda	Lialda
0023-5901	Asacol HD	mesalamine
0430-0783	ASACOL HD	mesalamine
0023-5853	Delzicol	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