mycophenolic acid

Generic: mycophenolic acid

Labeler: novugen pharma (usa) llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolic acid
Generic Name mycophenolic acid
Labeler novugen pharma (usa) llc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 180 mg/1

Manufacturer
Novugen Pharma (USA) LLC.

Identifiers & Regulatory

Product NDC 82293-012
Product ID 82293-012_1f0154d5-686f-170e-e063-6394a90a67e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216637
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82293012
Hyphenated Format 82293-012

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 ANDA216637 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-012-10)
source: ndc

Packages (1)

82293-012-10 120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-012-10)

Ingredients (1)

mycophenolate sodium (180 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": "1f0154d5-686f-170e-e063-6394a90a67e6", "openfda": {"unii": ["WX877SQI1G"], "rxcui": ["485020", "485023"], "spl_set_id": ["cbc3e916-09e2-4e6e-9e5e-98375f5e6d41"], "manufacturer_name": ["Novugen Pharma (USA) LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-012-10)", "package_ndc": "82293-012-10", "marketing_start_date": "20240901"}], "brand_name": "Mycophenolic Acid", "product_id": "82293-012_1f0154d5-686f-170e-e063-6394a90a67e6", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "82293-012", "generic_name": "Mycophenolic Acid", "labeler_name": "Novugen Pharma (USA) LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolic Acid", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "180 mg/1"}], "application_number": "ANDA216637", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}