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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

mycophenolate mofetil 200 mg/mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 0004-0261
Product ID 0004-0261_ad799779-cc87-4d12-9836-74375149b84b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050759
Listing Expiration 2026-12-31
Marketing Start 1998-10-01

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00040261
Hyphenated Format 0004-0261

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 NDA050759 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0004-0261-29 1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

mycophenolate mofetil (200 mg/mL)

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 (0004-0261-29)  / 225 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0004-0261-29", "marketing_start_date": "19981001"}], "brand_name": "CellCept", "product_id": "0004-0261_ad799779-cc87-4d12-9836-74375149b84b", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0004-0261", "generic_name": "Mycophenolate Mofetil", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CellCept", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL", "strength": "200 mg/mL"}], "application_number": "NDA050759", "marketing_category": "NDA", "marketing_start_date": "19981001", "listing_expiration_date": "20261231"}