mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-033
Product ID 71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065521
Listing Expiration 2026-12-31
Marketing Start 2015-01-06

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610033
Hyphenated Format 71610-033

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 ANDA065521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80)
  • 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90)
  • 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92)
  • 540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)
source: ndc

Packages (7)

71610-033-53 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53) 71610-033-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60) 71610-033-70 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70) 71610-033-80 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80) 71610-033-90 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90) 71610-033-92 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92) 71610-033-98 540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)

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": "11d3eb0d-489b-06c5-e063-6294a90a9d3b", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["200060"], "spl_set_id": ["721564bc-7c0b-4418-ab49-0af362e74eb7"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)", "package_ndc": "71610-033-53", "marketing_start_date": "20190701"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60)", "package_ndc": "71610-033-60", "marketing_start_date": "20190701"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70)", "package_ndc": "71610-033-70", "marketing_start_date": "20180119"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80)", "package_ndc": "71610-033-80", "marketing_start_date": "20190701"}, {"sample": false, "description": "240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90)", "package_ndc": "71610-033-90", "marketing_start_date": "20190701"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92)", "package_ndc": "71610-033-92", "marketing_start_date": "20190701"}, {"sample": false, "description": "540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)", "package_ndc": "71610-033-98", "marketing_start_date": "20190701"}], "brand_name": "Mycophenolate Mofetil", "product_id": "71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "71610-033", "generic_name": "mycophenolate mofetil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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_start_date": "20150106", "listing_expiration_date": "20261231"}