azathioprine

Generic: azathioprine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azathioprine
Generic Name azathioprine
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azathioprine 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-120
Product ID 68382-120_64e1751f-fdf5-45e7-ac57-6499c0b5aa91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077621
Listing Expiration 2026-12-31
Marketing Start 2017-12-02

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 68382120
Hyphenated Format 68382-120

Supplemental Identifiers

RxCUI
197388 199310 359228 359229
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 azathioprine (source: ndc)
Generic Name azathioprine (source: ndc)
Application Number ANDA077621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-120-01)
  • 500 TABLET in 1 BOTTLE (68382-120-05)
source: ndc

Packages (2)

68382-120-01 100 TABLET in 1 BOTTLE (68382-120-01) 68382-120-05 500 TABLET in 1 BOTTLE (68382-120-05)

Ingredients (1)

azathioprine (100 mg/1)

Linked Drug Pages (1)

Azathioprine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64e1751f-fdf5-45e7-ac57-6499c0b5aa91", "openfda": {"nui": ["N0000000233", "M0015066", "N0000175712", "M0018169"], "unii": ["MRK240IY2L"], "rxcui": ["197388", "199310", "359228", "359229"], "spl_set_id": ["b1b0fa3e-11c3-46d0-9537-6b372c2a1b56"], "pharm_class_cs": ["Nucleosides [CS]", "Purines [CS]"], "pharm_class_epc": ["Purine Antimetabolite [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-120-01)", "package_ndc": "68382-120-01", "marketing_start_date": "20171202"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-120-05)", "package_ndc": "68382-120-05", "marketing_start_date": "20171202"}], "brand_name": "Azathioprine", "product_id": "68382-120_64e1751f-fdf5-45e7-ac57-6499c0b5aa91", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleosides [CS]", "Purine Antimetabolite [EPC]", "Purines [CS]"], "product_ndc": "68382-120", "generic_name": "Azathioprine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azathioprine", "active_ingredients": [{"name": "AZATHIOPRINE", "strength": "100 mg/1"}], "application_number": "ANDA077621", "marketing_category": "ANDA", "marketing_start_date": "20171202", "listing_expiration_date": "20261231"}