mycophenolate mofetil

Generic: mycophenolate mofetil

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

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4377
Product ID 70518-4377_38dd4fa9-8b2d-47b6-e063-6294a90a1b7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090456
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184377
Hyphenated Format 70518-4377

Supplemental Identifiers

RxCUI
200060
UNII
9242ECW6R0

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 ANDA090456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4377-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4377-1)
source: ndc

Packages (1)

70518-4377-0 100 POUCH in 1 BOX (70518-4377-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4377-1)

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": "38dd4fa9-8b2d-47b6-e063-6294a90a1b7b", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["200060"], "spl_set_id": ["84c6f6bb-8924-4da5-9629-126197195f83"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4377-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-4377-1)", "package_ndc": "70518-4377-0", "marketing_start_date": "20250630"}], "brand_name": "Mycophenolate mofetil", "product_id": "70518-4377_38dd4fa9-8b2d-47b6-e063-6294a90a1b7b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "70518-4377", "generic_name": "Mycophenolate mofetil", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA090456", "marketing_category": "ANDA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}