mycophenolate mofetil

Generic: mycophenolate mofetil

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

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler concord biotech limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
CONCORD BIOTECH LIMITED

Identifiers & Regulatory

Product NDC 68254-5003
Product ID 68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212087
Listing Expiration 2026-12-31
Marketing Start 2020-12-21

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 682545003
Hyphenated Format 68254-5003

Supplemental Identifiers

RxCUI
199058 200060
UPC
0368254500333
UNII
9242ECW6R0

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 mycophenolate mofetil (source: ndc)
Generic Name mycophenolate mofetil (source: ndc)
Application Number ANDA212087 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68254-5003-1)
  • 100 TABLET in 1 BOTTLE (68254-5003-2)
  • 500 TABLET in 1 BOTTLE (68254-5003-3)
source: ndc

Packages (3)

68254-5003-1 30 TABLET in 1 BOTTLE (68254-5003-1) 68254-5003-2 100 TABLET in 1 BOTTLE (68254-5003-2) 68254-5003-3 500 TABLET in 1 BOTTLE (68254-5003-3)

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

MYCOPHENOLATE MOFETIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29", "openfda": {"upc": ["0368254500333"], "unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["64ac00ee-298c-49cf-a91c-78019a0d014d"], "manufacturer_name": ["CONCORD BIOTECH LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68254-5003-1)", "package_ndc": "68254-5003-1", "marketing_start_date": "20201221"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (68254-5003-2)", "package_ndc": "68254-5003-2", "marketing_start_date": "20201221"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68254-5003-3)", "package_ndc": "68254-5003-3", "marketing_start_date": "20201221"}], "brand_name": "MYCOPHENOLATE MOFETIL", "product_id": "68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29", "dosage_form": "TABLET", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "68254-5003", "generic_name": "MYCOPHENOLATE MOFETIL", "labeler_name": "CONCORD BIOTECH LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYCOPHENOLATE MOFETIL", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA212087", "marketing_category": "ANDA", "marketing_start_date": "20201221", "listing_expiration_date": "20261231"}