mycophenolic acid

Generic: mycophenolic acid

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

Drug Facts

Product Profile

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

mycophenolate sodium 360 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4391
Product ID 70518-4391_39f7886b-ec90-a8b4-e063-6394a90a9065
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208315
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184391
Hyphenated Format 70518-4391

Supplemental Identifiers

RxCUI
485023
UNII
WX877SQI1G

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 ANDA208315 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4391-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4391-1)
source: ndc

Packages (1)

70518-4391-0 30 POUCH in 1 BOX (70518-4391-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4391-1)

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": "39f7886b-ec90-a8b4-e063-6394a90a9065", "openfda": {"unii": ["WX877SQI1G"], "rxcui": ["485023"], "spl_set_id": ["bc98d9a1-b4e3-4085-a8ba-d3313246658a"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4391-0)  / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-4391-1)", "package_ndc": "70518-4391-0", "marketing_start_date": "20250715"}], "brand_name": "MYCOPHENOLIC ACID", "product_id": "70518-4391_39f7886b-ec90-a8b4-e063-6394a90a9065", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "70518-4391", "generic_name": "MYCOPHENOLIC ACID", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MYCOPHENOLIC ACID", "active_ingredients": [{"name": "MYCOPHENOLATE SODIUM", "strength": "360 mg/1"}], "application_number": "ANDA208315", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}