imuran

Generic: azathioprine

Labeler: sebela pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name imuran
Generic Name azathioprine
Labeler sebela pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azathioprine 50 mg/1

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-590
Product ID 54766-590_431426e8-80d4-a4e2-e063-6394a90af918
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016324
Marketing Start 2017-12-01
Marketing End 2028-04-30

Pharmacologic Class

Established (EPC)
purine antimetabolite [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]
Chemical Structure
nucleosides [cs] purines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54766590
Hyphenated Format 54766-590

Supplemental Identifiers

RxCUI
105611 197388
UPC
0354766590108
UNII
MRK240IY2L
NUI
N0000000233 M0015066 N0000175712 M0018169

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imuran (source: ndc)
Generic Name azathioprine (source: ndc)
Application Number NDA016324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (54766-590-10)
source: ndc

Packages (1)

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

Ingredients (1)

azathioprine (50 mg/1)

Linked Drug Pages (1)

IMURAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "431426e8-80d4-a4e2-e063-6394a90af918", "openfda": {"nui": ["N0000000233", "M0015066", "N0000175712", "M0018169"], "upc": ["0354766590108"], "unii": ["MRK240IY2L"], "rxcui": ["105611", "197388"], "spl_set_id": ["606101a0-6244-7eff-e053-2a91aa0acadd"], "pharm_class_cs": ["Nucleosides [CS]", "Purines [CS]"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (54766-590-10)", "package_ndc": "54766-590-10", "marketing_end_date": "20280430", "marketing_start_date": "20171201"}], "brand_name": "IMURAN", "product_id": "54766-590_431426e8-80d4-a4e2-e063-6394a90af918", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleosides [CS]", "Purine Antimetabolite [EPC]", "Purines [CS]"], "product_ndc": "54766-590", "generic_name": "azathioprine", "labeler_name": "Sebela Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMURAN", "active_ingredients": [{"name": "AZATHIOPRINE", "strength": "50 mg/1"}], "application_number": "NDA016324", "marketing_category": "NDA", "marketing_end_date": "20280430", "marketing_start_date": "20171201"}