NDC 54766-590

IMURAN

Azathioprine

IMURAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Azathioprine.

• Product ID: 54766-590_84897784-a8ea-4408-e053-2991aa0a9b9d
• NDC: 54766-590
• Product Type: Human Prescription Drug
• Proprietary Name: IMURAN
• Generic Name: Azathioprine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA016324
• Labeler Name: Sebela Pharmaceuticals Inc.
• Substance Name: AZATHIOPRINE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleosides [CS],Purine Antimetabolite [EPC],Purines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54766-590-10

100 TABLET in 1 BOTTLE (54766-590-10)

• Marketing Start Date: 2017-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54766-590-10 [54766059010]

IMURAN TABLET

• Marketing Category: NDA
• Application Number: NDA016324
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-01

Drug Details

Active Ingredients

Ingredient	Strength
AZATHIOPRINE	50 mg/1

OpenFDA Data

• SPL SET ID: 606101a0-6244-7eff-e053-2a91aa0acadd
• Manufacturer:
  • Sebela Pharmaceuticals Inc.
• UNII:
  • MRK240IY2L
• RxNorm Concept Unique ID - RxCUI:
  • 105611
  • 197388
• UPC Code:
  • 0354766590108

Pharmacological Class

• Nucleoside Analog [EXT]
• Purine Antimetabolite [EPC]
• Purines [CS]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleosides [CS]
• Purine Antimetabolite [EPC]
• Purines [CS]

NDC Crossover Matching brand name "IMURAN" or generic name "Azathioprine"

NDC	Brand Name	Generic Name
54766-590	IMURAN	azathioprine
65483-590	IMURAN	azathioprine
65649-231	Azasan	Azathioprine
65649-241	Azasan	Azathioprine
0378-1005	Azathioprine	azathioprine
0615-7568	Azathioprine	Azathioprine
21695-484	Azathioprine	Azathioprine
33261-758	Azathioprine	Azathioprine
42291-071	AZATHIOPRINE	Azathioprine
43353-745	Azathioprine	azathioprine
51079-620	Azathioprine	azathioprine
51407-182	Azathioprine	Azathioprine
60219-1076	AZATHIOPRINE	Azathioprine
60219-2036	AZATHIOPRINE	Azathioprine
60219-2037	AZATHIOPRINE	Azathioprine
65841-602	Azathioprine	Azathioprine