mycophenolate mofetil

Generic: mycophenolate mofetil

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

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0166
Product ID 0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065413
Listing Expiration 2026-12-31
Marketing Start 2008-07-29

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540166
Hyphenated Format 0054-0166

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 ANDA065413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0054-0166-25)
  • 500 TABLET in 1 BOTTLE (0054-0166-29)
source: ndc

Packages (2)

0054-0166-25 100 TABLET in 1 BOTTLE (0054-0166-25) 0054-0166-29 500 TABLET in 1 BOTTLE (0054-0166-29)

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": "d938a1b7-eed3-4e23-bfef-f88c443d9267", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["e94895d9-f040-4a75-9f04-9814238b8f3c"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0166-25)", "package_ndc": "0054-0166-25", "marketing_start_date": "20080729"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0054-0166-29)", "package_ndc": "0054-0166-29", "marketing_start_date": "20080729"}], "brand_name": "Mycophenolate Mofetil", "product_id": "0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267", "dosage_form": "TABLET", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0054-0166", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA065413", "marketing_category": "ANDA", "marketing_start_date": "20080729", "listing_expiration_date": "20261231"}