mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mycophenolate mofetil 500 mg/20mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-386
Product ID 67457-386_4c643876-2577-4197-ac9b-81bab65d1362
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203859
Listing Expiration 2026-12-31
Marketing Start 2021-01-26

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457386
Hyphenated Format 67457-386

Supplemental Identifiers

RxCUI
311881
UNII
9242ECW6R0

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 mycophenolate mofetil (source: ndc)
Generic Name mycophenolate mofetil (source: ndc)
Application Number ANDA203859 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00)
source: ndc

Packages (1)

67457-386-81 4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00)

Ingredients (1)

mycophenolate mofetil (500 mg/20mL)

Linked Drug Pages (1)

Mycophenolate Mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4c643876-2577-4197-ac9b-81bab65d1362", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["311881"], "spl_set_id": ["da02b428-42a4-4007-b0b7-695f2db010f2"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (67457-386-81)  / 20 mL in 1 VIAL (67457-386-00)", "package_ndc": "67457-386-81", "marketing_start_date": "20210126"}], "brand_name": "Mycophenolate Mofetil", "product_id": "67457-386_4c643876-2577-4197-ac9b-81bab65d1362", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "67457-386", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/20mL"}], "application_number": "ANDA203859", "marketing_category": "ANDA", "marketing_start_date": "20210126", "listing_expiration_date": "20261231"}