cellcept

Generic: mycophenolate mofetil hydrochloride

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

Drug Facts

Product Profile

Brand Name cellcept
Generic Name mycophenolate mofetil hydrochloride
Labeler genentech, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mycophenolate mofetil hydrochloride 500 mg/20mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 0004-0298
Product ID 0004-0298_ad799779-cc87-4d12-9836-74375149b84b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050758
Listing Expiration 2026-12-31
Marketing Start 1998-08-12

Pharmacologic Class

Classes
antimetabolite immunosuppressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00040298
Hyphenated Format 0004-0298

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 hydrochloride (source: ndc)
Application Number NDA050758 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0004-0298-09 4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL

Ingredients (1)

mycophenolate mofetil hydrochloride (500 mg/20mL)

Linked Drug Pages (1)

CellCept ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "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": "4 VIAL in 1 CARTON (0004-0298-09)  / 20 mL in 1 VIAL", "package_ndc": "0004-0298-09", "marketing_start_date": "19980812"}], "brand_name": "CellCept", "product_id": "0004-0298_ad799779-cc87-4d12-9836-74375149b84b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite Immunosuppressant [EPC]"], "product_ndc": "0004-0298", "generic_name": "Mycophenolate Mofetil hydrochloride", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CellCept", "active_ingredients": [{"name": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE", "strength": "500 mg/20mL"}], "application_number": "NDA050758", "marketing_category": "NDA", "marketing_start_date": "19980812", "listing_expiration_date": "20261231"}