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 CAPSULE
Routes
ORAL
Active Ingredients

mycophenolate mofetil 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3799
Product ID 70518-3799_3b2912ad-1721-3d82-e063-6394a90ad4fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090055
Listing Expiration 2026-12-31
Marketing Start 2023-07-18

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183799
Hyphenated Format 70518-3799

Supplemental Identifiers

RxCUI
199058
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 ANDA090055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1)
source: ndc

Packages (1)

70518-3799-0 100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1)

Ingredients (1)

mycophenolate mofetil (250 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": "3b2912ad-1721-3d82-e063-6394a90ad4fc", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["199058"], "spl_set_id": ["77a75d5b-a90d-4ee5-aa8a-6da97d130357"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-3799-0)  / 1 CAPSULE in 1 POUCH (70518-3799-1)", "package_ndc": "70518-3799-0", "marketing_start_date": "20230718"}], "brand_name": "Mycophenolate mofetil", "product_id": "70518-3799_3b2912ad-1721-3d82-e063-6394a90ad4fc", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "70518-3799", "generic_name": "Mycophenolate mofetil", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "250 mg/1"}], "application_number": "ANDA090055", "marketing_category": "ANDA", "marketing_start_date": "20230718", "listing_expiration_date": "20261231"}