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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-638
Product ID 59651-638_abdd39b5-dac9-4e5c-9722-17473947909d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217937
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651638
Hyphenated Format 59651-638

Supplemental Identifiers

RxCUI
200060
UPC
0359651638019
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 ANDA217937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05)
source: ndc

Packages (2)

59651-638-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01) 59651-638-05 500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05)

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": "abdd39b5-dac9-4e5c-9722-17473947909d", "openfda": {"upc": ["0359651638019"], "unii": ["9242ECW6R0"], "rxcui": ["200060"], "spl_set_id": ["8faf357b-99a1-440b-8eac-8545cb19a69c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-638-01)", "package_ndc": "59651-638-01", "marketing_start_date": "20240220"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59651-638-05)", "package_ndc": "59651-638-05", "marketing_start_date": "20240220"}], "brand_name": "Mycophenolate Mofetil", "product_id": "59651-638_abdd39b5-dac9-4e5c-9722-17473947909d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "59651-638", "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": "500 mg/1"}], "application_number": "ANDA217937", "marketing_category": "ANDA", "marketing_start_date": "20240220", "listing_expiration_date": "20261231"}