mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-019
Product ID 16729-019_4250c98b-b140-b123-e063-6394a90a30cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065416
Listing Expiration 2026-12-31
Marketing Start 2009-05-04

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729019
Hyphenated Format 16729-019

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 ANDA065416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-019-01)
  • 500 TABLET in 1 BOTTLE (16729-019-16)
source: ndc

Packages (2)

16729-019-01 100 TABLET in 1 BOTTLE (16729-019-01) 16729-019-16 500 TABLET in 1 BOTTLE (16729-019-16)

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": "4250c98b-b140-b123-e063-6394a90a30cc", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["741e079a-646b-47ec-84ac-8e12574c2aaf"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-019-01)", "package_ndc": "16729-019-01", "marketing_start_date": "20090504"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16729-019-16)", "package_ndc": "16729-019-16", "marketing_start_date": "20090504"}], "brand_name": "mycophenolate mofetil", "product_id": "16729-019_4250c98b-b140-b123-e063-6394a90a30cc", "dosage_form": "TABLET", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "16729-019", "generic_name": "mycophenolate mofetil", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA065416", "marketing_category": "ANDA", "marketing_start_date": "20090504", "listing_expiration_date": "20261231"}