mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mycophenolate mofetil 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-033
Product ID 82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090456
Listing Expiration 2026-12-31
Marketing Start 2022-10-15

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804033
Hyphenated Format 82804-033

Supplemental Identifiers

RxCUI
200060
UPC
0382804033300
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 ANDA090456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)
source: ndc

Packages (3)

82804-033-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30) 82804-033-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60) 82804-033-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)

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": "ce06afcb-4e6c-4b78-8bad-9909c8fffa52", "openfda": {"upc": ["0382804033300"], "unii": ["9242ECW6R0"], "rxcui": ["200060"], "spl_set_id": ["ce06afcb-4e6c-4b78-8bad-9909c8fffa52"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30)", "package_ndc": "82804-033-30", "marketing_start_date": "20231025"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60)", "package_ndc": "82804-033-60", "marketing_start_date": "20231025"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)", "package_ndc": "82804-033-90", "marketing_start_date": "20231025"}], "brand_name": "Mycophenolate mofetil", "product_id": "82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "82804-033", "generic_name": "Mycophenolate mofetil", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA090456", "marketing_category": "ANDA", "marketing_start_date": "20221015", "listing_expiration_date": "20261231"}