mycophenolate mofetil

Generic: mycophenolate mofetil

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

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mycophenolate mofetil 500 mg/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-803
Product ID 71288-803_57acc3ef-fe59-4e7b-8df3-396bdb4bb5c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212130
Listing Expiration 2026-12-31
Marketing Start 2021-01-15

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288803
Hyphenated Format 71288-803

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 ANDA212130 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91)
source: ndc

Packages (1)

71288-803-92 4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91)

Ingredients (1)

mycophenolate mofetil (500 mg/20mL)

Linked Drug Pages (2)

Mycophenolate Mofetil ndc-match (0.9) Mycophenolate Mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "57acc3ef-fe59-4e7b-8df3-396bdb4bb5c5", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["311881"], "spl_set_id": ["b41cca9f-0922-4171-8d1b-8e0d32ae1cc1"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92)  / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91)", "package_ndc": "71288-803-92", "marketing_start_date": "20210115"}], "brand_name": "Mycophenolate Mofetil", "product_id": "71288-803_57acc3ef-fe59-4e7b-8df3-396bdb4bb5c5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "71288-803", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/20mL"}], "application_number": "ANDA212130", "marketing_category": "ANDA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}