mycophenolate mofetil

Generic: mycophenolate mofetil hydrochloride

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil hydrochloride
Labeler bpi labs llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mycophenolate mofetil hydrochloride 500 mg/20mL

Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-141
Product ID 54288-141_1a8abd3a-6834-4468-a443-ca95e795b17d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214283
Listing Expiration 2026-12-31
Marketing Start 2023-03-08

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288141
Hyphenated Format 54288-141

Supplemental Identifiers

RxCUI
311881
UPC
0354288141017 0354288141048
UNII
UXH81S8ZVB

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 hydrochloride (source: ndc)
Application Number ANDA214283 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL
source: ndc

Packages (1)

54288-141-04 4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL

Ingredients (1)

mycophenolate mofetil hydrochloride (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": "1a8abd3a-6834-4468-a443-ca95e795b17d", "openfda": {"upc": ["0354288141017", "0354288141048"], "unii": ["UXH81S8ZVB"], "rxcui": ["311881"], "spl_set_id": ["32001417-130d-4c08-8e63-94ba3627ce5f"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (54288-141-04)  / 20 mL in 1 VIAL", "package_ndc": "54288-141-04", "marketing_start_date": "20230308"}], "brand_name": "Mycophenolate Mofetil", "product_id": "54288-141_1a8abd3a-6834-4468-a443-ca95e795b17d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "54288-141", "generic_name": "Mycophenolate Mofetil hydrochloride", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE", "strength": "500 mg/20mL"}], "application_number": "ANDA214283", "marketing_category": "ANDA", "marketing_start_date": "20230308", "listing_expiration_date": "20261231"}