mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mycophenolate mofetil 500 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7078
Product ID 0904-7078_f2afb582-0575-44fd-95f9-9a019638ea6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090456
Listing Expiration 2026-12-31
Marketing Start 2010-11-06

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047078
Hyphenated Format 0904-7078

Supplemental Identifiers

RxCUI
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 ANDA090456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CAPSULE (0904-7078-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7078-61 100 BLISTER PACK in 1 CAPSULE (0904-7078-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "f2afb582-0575-44fd-95f9-9a019638ea6c", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["200060"], "spl_set_id": ["d176199c-dc3f-48c8-b7d2-c5d0a6a242fe"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CAPSULE (0904-7078-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7078-61", "marketing_start_date": "20101106"}], "brand_name": "Mycophenolate mofetil", "product_id": "0904-7078_f2afb582-0575-44fd-95f9-9a019638ea6c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0904-7078", "generic_name": "Mycophenolate mofetil", "labeler_name": "Major Pharmaceuticals", "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": "20101106", "listing_expiration_date": "20261231"}