mycophenolic acid

Generic: mycophenolic acid

Labeler: concord biotech limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenolic acid
Labeler concord biotech limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 360 mg/1

Manufacturer
CONCORD BIOTECH LIMITED

Identifiers & Regulatory

Product NDC 68254-5002
Product ID 68254-5002_47ef003d-aa2a-4b8e-9ab4-bba4cde21f09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211173
Listing Expiration 2026-12-31
Marketing Start 2019-12-13

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 682545002
Hyphenated Format 68254-5002

Supplemental Identifiers

RxCUI
485020 485023
UNII
WX877SQI1G

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 mycophenolic acid (source: ndc)
Generic Name mycophenolic acid (source: ndc)
Application Number ANDA211173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-1)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-2)
source: ndc

Packages (2)

68254-5002-1 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-1) 68254-5002-2 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-2)

Ingredients (1)

mycophenolate sodium (360 mg/1)

Linked Drug Pages (1)

mycophenolic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47ef003d-aa2a-4b8e-9ab4-bba4cde21f09", "openfda": {"unii": ["WX877SQI1G"], "rxcui": ["485020", "485023"], "spl_set_id": ["a374549e-8afd-48fe-ae3f-368984689a2a"], "manufacturer_name": ["CONCORD BIOTECH LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-1)", "package_ndc": "68254-5002-1", "marketing_start_date": "20191213"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-2)", "package_ndc": "68254-5002-2", "marketing_start_date": "20191213"}], "brand_name": "mycophenolic acid", "product_id": "68254-5002_47ef003d-aa2a-4b8e-9ab4-bba4cde21f09", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "68254-5002", "generic_name": "mycophenolic acid", "labeler_name": "CONCORD BIOTECH LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mycophenolic acid", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "360 mg/1"}], "application_number": "ANDA211173", "marketing_category": "ANDA", "marketing_start_date": "20191213", "listing_expiration_date": "20261231"}