mycophenolate mofetil

Generic: mycophenolate mofetil

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycophenolate mofetil
Generic Name mycophenolate mofetil
Labeler strides pharma science limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mycophenolate mofetil 500 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-725
Product ID 64380-725_51752987-c49c-40b6-8fe2-1d1c99554312
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090456
Listing Expiration 2027-12-31
Marketing Start 2010-11-06

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380725
Hyphenated Format 64380-725

Supplemental Identifiers

RxCUI
199058 200060
UPC
0364380726067 0364380725060
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 ANDA090456 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-06)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-07)
source: ndc

Packages (2)

64380-725-06 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-06) 64380-725-07 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-07)

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": "51752987-c49c-40b6-8fe2-1d1c99554312", "openfda": {"upc": ["0364380726067", "0364380725060"], "unii": ["9242ECW6R0"], "rxcui": ["199058", "200060"], "spl_set_id": ["32dd890a-cfe3-4129-bce6-1d3dbe38e4f3"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-06)", "package_ndc": "64380-725-06", "marketing_start_date": "20101106"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-725-07)", "package_ndc": "64380-725-07", "marketing_start_date": "20101106"}], "brand_name": "Mycophenolate mofetil", "product_id": "64380-725_51752987-c49c-40b6-8fe2-1d1c99554312", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "64380-725", "generic_name": "Mycophenolate mofetil", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycophenolate mofetil", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "ANDA090456", "marketing_category": "ANDA", "marketing_start_date": "20101106", "listing_expiration_date": "20271231"}