mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler lannett company, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

mycophenolate mofetil 200 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-5160
Product ID 0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214525
Listing Expiration 2026-12-31
Marketing Start 2021-07-29

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05275160
Hyphenated Format 0527-5160

Supplemental Identifiers

RxCUI
311880
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 ANDA214525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0527-5160-82 1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

mycophenolate mofetil (200 mg/mL)

Linked Drug Pages (1)

Mycophenolate Mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6cb7ed46-e457-4e92-8a15-e771e3dca2d5", "openfda": {"unii": ["9242ECW6R0"], "rxcui": ["311880"], "spl_set_id": ["24c0b94a-c141-44b6-a6f0-ade1669b254c"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82)  / 225 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0527-5160-82", "marketing_start_date": "20210729"}], "brand_name": "Mycophenolate Mofetil", "product_id": "0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0527-5160", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "200 mg/mL"}], "application_number": "ANDA214525", "marketing_category": "ANDA", "marketing_start_date": "20210729", "listing_expiration_date": "20261231"}