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 CAPSULE
Routes
ORAL
Active Ingredients

mycophenolate mofetil 250 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-557
Product ID 50268-557_47e7bafd-1b50-c454-e063-6394a90a6868
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200197
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 50268557
Hyphenated Format 50268-557

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 ANDA200197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11)
source: ndc

Packages (1)

50268-557-15 50 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11)

Ingredients (1)

mycophenolate mofetil (250 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 (50268-557-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-557-11)", "package_ndc": "50268-557-15", "marketing_start_date": "20230515"}], "brand_name": "mycophenolate mofetil", "product_id": "50268-557_47e7bafd-1b50-c454-e063-6394a90a6868", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "50268-557", "generic_name": "mycophenolate mofetil", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "250 mg/1"}], "application_number": "ANDA200197", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20271231"}