mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-558
Product ID 50268-558_47e7bafd-1b50-c454-e063-6394a90a6868
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091249
Listing Expiration 2027-12-31
Marketing Start 2023-05-15

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268558
Hyphenated Format 50268-558

Supplemental Identifiers

RxCUI
199058 200060
UNII
9242ECW6R0

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 ANDA091249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-558-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-558-11)
source: ndc

Packages (1)

50268-558-15 50 BLISTER PACK in 1 BOX (50268-558-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-558-11)

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

mycophenolate mofetil, Mycophenolate Mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e7bafd-1b50-c454-e063-6394a90a6868", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["fbbe6521-0e21-5372-e053-6394a90ae5e4"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-558-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-558-11)", "package_ndc": "50268-558-15", "marketing_start_date": "20230515"}], "brand_name": "Mycophenolate Mofetil", "product_id": "50268-558_47e7bafd-1b50-c454-e063-6394a90a6868", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "50268-558", "generic_name": "Mycophenolate Mofetil", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA091249", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20271231"}