mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4472
Product ID 0378-4472_c55e1a32-db7a-4605-bab0-972a88414e7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065521
Marketing Start 2009-05-04
Marketing End 2026-05-31

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784472
Hyphenated Format 0378-4472

Supplemental Identifiers

RxCUI
199058 200060
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 ANDA065521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05)
source: ndc

Packages (1)

0378-4472-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05)

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": "c55e1a32-db7a-4605-bab0-972a88414e7e", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["74c3a01e-9451-0f2f-6aab-8348047cb1f5"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05)", "package_ndc": "0378-4472-05", "marketing_end_date": "20260531", "marketing_start_date": "20090504"}], "brand_name": "Mycophenolate Mofetil", "product_id": "0378-4472_c55e1a32-db7a-4605-bab0-972a88414e7e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0378-4472", "generic_name": "mycophenolate mofetil", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA065521", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20090504"}