mycophenolic acid

Generic: mycophenolic acid

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

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenolic acid
Labeler accord healthcare inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 360 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-189
Product ID 16729-189_0f1eadde-f71c-76cb-e063-6294a90af04c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202555
Listing Expiration 2026-12-31
Marketing Start 2017-09-11

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729189
Hyphenated Format 16729-189

Supplemental Identifiers

RxCUI
485020 485023
UNII
WX877SQI1G

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 mycophenolic acid (source: ndc)
Generic Name mycophenolic acid (source: ndc)
Application Number ANDA202555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-16)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-29)
source: ndc

Packages (2)

16729-189-16 500 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-16) 16729-189-29 120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-29)

Ingredients (1)

mycophenolate sodium (360 mg/1)

Linked Drug Pages (1)

Mycophenolic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f1eadde-f71c-76cb-e063-6294a90af04c", "openfda": {"unii": ["WX877SQI1G"], "rxcui": ["485020", "485023"], "spl_set_id": ["dc24aa15-330c-4698-872f-159d7e582b4b"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-16)", "package_ndc": "16729-189-16", "marketing_start_date": "20260101"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-29)", "package_ndc": "16729-189-29", "marketing_start_date": "20170911"}], "brand_name": "Mycophenolic Acid", "product_id": "16729-189_0f1eadde-f71c-76cb-e063-6294a90af04c", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "16729-189", "generic_name": "Mycophenolic Acid", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolic Acid", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "360 mg/1"}], "application_number": "ANDA202555", "marketing_category": "ANDA", "marketing_start_date": "20170911", "listing_expiration_date": "20261231"}