mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler sandoz inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5175
Product ID 0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065451
Listing Expiration 2026-12-31
Marketing Start 2008-10-15

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07815175
Hyphenated Format 0781-5175

Supplemental Identifiers

RxCUI
199058 200060
UPC
0307812067017
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 ANDA065451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10)
source: ndc

Packages (3)

0781-5175-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01) 0781-5175-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05) 0781-5175-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10)

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

Mycophenolate Mofetil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d255117-cfa8-4893-8e2e-945eee7b12c4", "openfda": {"upc": ["0307812067017"], "unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["99b2eb58-8d14-48fc-bbe1-aacb711a783e"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01)", "package_ndc": "0781-5175-01", "marketing_start_date": "20081015"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05)", "package_ndc": "0781-5175-05", "marketing_start_date": "20081015"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10)", "package_ndc": "0781-5175-10", "marketing_start_date": "20081015"}], "brand_name": "Mycophenolate Mofetil", "product_id": "0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0781-5175", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate Mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA065451", "marketing_category": "ANDA", "marketing_start_date": "20081015", "listing_expiration_date": "20261231"}