mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: onesource specialty pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler onesource specialty pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mycophenolate mofetil 500 mg/20mL

Manufacturer
ONESOURCE SPECIALTY PHARMA LIMITED

Identifiers & Regulatory

Product NDC 83270-000
Product ID 83270-000_42ed2be4-bc3d-281a-e063-6394a90aeb7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216390
Listing Expiration 2026-12-31
Marketing Start 2023-04-30

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83270000
Hyphenated Format 83270-000

Supplemental Identifiers

RxCUI
311881
UPC
0383270000018
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 ANDA216390 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL
source: ndc

Packages (1)

83270-000-04 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL

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": "42ed2be4-bc3d-281a-e063-6394a90aeb7f", "openfda": {"upc": ["0383270000018"], "unii": ["9242ECW6R0"], "rxcui": ["311881"], "spl_set_id": ["461a252f-ff81-4e08-b256-a497b14835fa"], "manufacturer_name": ["ONESOURCE SPECIALTY PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (83270-000-04)  / 20 mL in 1 VIAL", "package_ndc": "83270-000-04", "marketing_start_date": "20230430"}], "brand_name": "mycophenolate mofetil", "product_id": "83270-000_42ed2be4-bc3d-281a-e063-6394a90aeb7f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "83270-000", "generic_name": "mycophenolate mofetil", "labeler_name": "ONESOURCE SPECIALTY PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/20mL"}], "application_number": "ANDA216390", "marketing_category": "ANDA", "marketing_start_date": "20230430", "listing_expiration_date": "20261231"}