mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-225
Product ID 67877-225_073c9f8d-f73a-481e-940c-9903dd4fff23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091249
Listing Expiration 2026-12-31
Marketing Start 2011-11-28

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877225
Hyphenated Format 67877-225

Supplemental Identifiers

RxCUI
199058 200060
UPC
0367877266053 0367877266015 0367877225050
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 ANDA091249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05)
  • 10 BLISTER PACK in 1 CARTON (67877-225-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (67877-225-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

67877-225-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01) 67877-225-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05) 67877-225-38 10 BLISTER PACK in 1 CARTON (67877-225-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK 67877-225-84 3 BLISTER PACK in 1 CARTON (67877-225-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

Mycophenolate Mofetil, mycophenolate mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "073c9f8d-f73a-481e-940c-9903dd4fff23", "openfda": {"upc": ["0367877266053", "0367877266015", "0367877225050"], "unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["9f84ea84-2d8b-4d91-a33f-7dfb5df937dc"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01)", "package_ndc": "67877-225-01", "marketing_start_date": "20111128"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05)", "package_ndc": "67877-225-05", "marketing_start_date": "20111128"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-225-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-225-38", "marketing_start_date": "20111128"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67877-225-84)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-225-84", "marketing_start_date": "20111128"}], "brand_name": "Mycophenolate Mofetil", "product_id": "67877-225_073c9f8d-f73a-481e-940c-9903dd4fff23", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "67877-225", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA091249", "marketing_category": "ANDA", "marketing_start_date": "20111128", "listing_expiration_date": "20261231"}