mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

mycophenolate mofetil 200 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-646
Product ID 59651-646_83531645-459d-4746-bc46-2d32928e9417
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218227
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651646
Hyphenated Format 59651-646

Supplemental Identifiers

RxCUI
311880
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 ANDA218227 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-646-26 1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE

Ingredients (1)

mycophenolate mofetil (200 mg/mL)

Linked Drug Pages (1)

MYCOPHENOLATE MOFETIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "83531645-459d-4746-bc46-2d32928e9417", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["311880"], "spl_set_id": ["20fa7709-a203-481f-aaf4-e98fab1acd0d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-646-26)  / 225 mL in 1 BOTTLE", "package_ndc": "59651-646-26", "marketing_start_date": "20240926"}], "brand_name": "MYCOPHENOLATE MOFETIL", "product_id": "59651-646_83531645-459d-4746-bc46-2d32928e9417", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "59651-646", "generic_name": "mycophenolate mofetil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYCOPHENOLATE MOFETIL", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "200 mg/mL"}], "application_number": "ANDA218227", "marketing_category": "ANDA", "marketing_start_date": "20240926", "listing_expiration_date": "20261231"}