myfortic

Generic: mycophenolic acid

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name myfortic
Generic Name mycophenolic acid
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mycophenolate sodium 180 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0385
Product ID 0078-0385_c5665f04-bf64-4cc7-b98b-171a8f57155b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050791
Listing Expiration 2026-12-31
Marketing Start 2004-02-27

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780385
Hyphenated Format 0078-0385

Supplemental Identifiers

RxCUI
485020 485023 616449 616450
UPC
0300780386661
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 myfortic (source: ndc)
Generic Name mycophenolic acid (source: ndc)
Application Number NDA050791 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)
source: ndc

Packages (1)

0078-0385-66 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)

Ingredients (1)

mycophenolate sodium (180 mg/1)

Linked Drug Pages (1)

Myfortic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c5665f04-bf64-4cc7-b98b-171a8f57155b", "openfda": {"upc": ["0300780386661"], "unii": ["WX877SQI1G"], "rxcui": ["485020", "485023", "616449", "616450"], "spl_set_id": ["eed26501-890d-4ff6-88e7-6dbea4726e53"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)", "package_ndc": "0078-0385-66", "marketing_start_date": "20040227"}], "brand_name": "Myfortic", "product_id": "0078-0385_c5665f04-bf64-4cc7-b98b-171a8f57155b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0078-0385", "generic_name": "mycophenolic acid", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myfortic", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "180 mg/1"}], "application_number": "NDA050791", "marketing_category": "NDA", "marketing_start_date": "20040227", "listing_expiration_date": "20261231"}