cellcept

Generic: mycophenolate mofetil

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

mycophenolate mofetil 500 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 0004-0260
Product ID 0004-0260_ad799779-cc87-4d12-9836-74375149b84b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050723
Listing Expiration 2026-12-31
Marketing Start 1997-06-19

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00040260
Hyphenated Format 0004-0260

Supplemental Identifiers

RxCUI
199058 200060 213394 311880 311881 616435 616444 616447
UNII
9242ECW6R0 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 cellcept (source: ndc)
Generic Name mycophenolate mofetil (source: ndc)
Application Number NDA050723 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

0004-0260-01 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 0004-0260-43 1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

mycophenolate mofetil (500 mg/1)

Linked Drug Pages (1)

CellCept ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad799779-cc87-4d12-9836-74375149b84b", "openfda": {"unii": ["9242ECW6R0", "UXH81S8ZVB"], "rxcui": ["199058", "200060", "213394", "311880", "311881", "616435", "616444", "616447"], "spl_set_id": ["37241e87-4af4-4dc3-a1aa-ea6f20d8dc40"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "0004-0260-01", "marketing_start_date": "19970619"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43)  / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "0004-0260-43", "marketing_start_date": "19970619"}], "brand_name": "CellCept", "product_id": "0004-0260_ad799779-cc87-4d12-9836-74375149b84b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0004-0260", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CellCept", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "500 mg/1"}], "application_number": "NDA050723", "marketing_category": "NDA", "marketing_start_date": "19970619", "listing_expiration_date": "20261231"}