NDC 0004-0298

CellCept

Mycophenolate Mofetil Hydrochloride

CellCept is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Mycophenolate Mofetil Hydrochloride.

• Product ID: 0004-0298_069ac782-5550-41a9-9179-bc1e44430526
• NDC: 0004-0298
• Product Type: Human Prescription Drug
• Proprietary Name: CellCept
• Generic Name: Mycophenolate Mofetil Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1998-08-12
• Marketing Category: NDA / NDA
• Application Number: NDA050758
• Labeler Name: Genentech, Inc.
• Substance Name: MYCOPHENOLATE MOFETIL HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/20mL
• Pharm Classes: Antimetabolite Immunosuppressant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0004-0298-09

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

• Marketing Start Date: 1998-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-0298-09 [00004029809]

CellCept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050758
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-12

Drug Details

Active Ingredients

Ingredient	Strength
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500 mg/20mL

OpenFDA Data

• SPL SET ID: 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 9242ECW6R0
  • UXH81S8ZVB
• RxNorm Concept Unique ID - RxCUI:
  • 311881
  • 311880
  • 200060
  • 616447
  • 616444
  • 199058
  • 616435
  • 213394

Pharmacological Class

• Antimetabolite Immunosuppressant [EPC]

NDC Crossover Matching brand name "CellCept" or generic name "Mycophenolate Mofetil Hydrochloride"

NDC	Brand Name	Generic Name
0004-0259	CellCept	Mycophenolate Mofetil
0004-0260	CellCept	Mycophenolate Mofetil
0004-0261	CellCept	Mycophenolate Mofetil
0004-0298	CellCept	Mycophenolate Mofetil hydrochloride
21695-171	CellCept	Mycophenolate Mofetil