NDC 60687-438

Mycophenolate mofetil

Mycophenolate Mofetil

Mycophenolate mofetil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Mycophenolate Mofetil.

• Product ID: 60687-438_87c055d7-31ba-6a83-e053-2a95a90a9035
• NDC: 60687-438
• Product Type: Human Prescription Drug
• Proprietary Name: Mycophenolate mofetil
• Generic Name: Mycophenolate Mofetil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090456
• Labeler Name: American Health Packaging
• Substance Name: MYCOPHENOLATE MOFETIL
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Antimetabolite Immunosuppressant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 60687-438-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11)

• Marketing Start Date: 2019-06-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60687-438-11 [60687043811]

Mycophenolate mofetil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-15

NDC 60687-438-01 [60687043801]

Mycophenolate mofetil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-15

Drug Details

Active Ingredients

Ingredient	Strength
MYCOPHENOLATE MOFETIL	500 mg/1

OpenFDA Data

• SPL SET ID: 8015f042-54fb-4a7a-a10b-6219e1a450c8
• Manufacturer:
  • American Health Packaging
• UNII:
  • 9242ECW6R0
• RxNorm Concept Unique ID - RxCUI:
  • 199058
  • 200060

Pharmacological Class

• Antimetabolite Immunosuppressant [EPC]
• Antimetabolite Immunosuppressant [EPC]

NDC Crossover Matching brand name "Mycophenolate mofetil" or generic name "Mycophenolate Mofetil"

NDC	Brand Name	Generic Name
0054-0163	Mycophenolate Mofetil	Mycophenolate Mofetil
0054-0166	Mycophenolate Mofetil	Mycophenolate Mofetil
0093-7334	Mycophenolate Mofetil	Mycophenolate Mofetil
67877-225	Mycophenolate Mofetil	Mycophenolate Mofetil
67877-230	Mycophenolate mofetil	Mycophenolate mofetil
67877-266	mycophenolate mofetil	mycophenolate mofetil
68084-795	Mycophenolate Mofetil	Mycophenolate Mofetil
68084-801	Mycophenolate mofetil	Mycophenolate mofetil
68254-5000	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL
68382-130	Mycophenolate Mofetil	Mycophenolate Mofetil
68382-131	Mycophenolate Mofetil	Mycophenolate Mofetil
68382-669	Mycophenolate Mofetil	Mycophenolate Mofetil
69189-0164	Mycophenolate Mofetil	Mycophenolate Mofetil
70771-1084	Mycophenolate Mofetil	Mycophenolate Mofetil
71610-033	Mycophenolate Mofetil	Mycophenolate Mofetil
0781-2067	Mycophenolate Mofetil	Mycophenolate Mofetil
0781-5175	Mycophenolate Mofetil	Mycophenolate Mofetil
16729-094	mycophenolate mofetil	mycophenolate mofetil
17478-422	Mycophenolate Mofetil	Mycophenolate Mofetil
17478-957	Mycophenolate Mofetil	Mycophenolate Mofetil
16729-019	mycophenolate mofetil	mycophenolate mofetil
0093-7477	mycophenolate mofetil	mycophenolate mofetil
42023-172	Mycophenolate Mofetil	Mycophenolate Mofetil
42658-101	Mycophenolate Mofetil	Mycophenolate Mofetil
42658-501	Mycophenolate Mofetil	Mycophenolate Mofetil
50090-2246	Mycophenolate mofetil	Mycophenolate mofetil
50090-2541	mycophenolate mofetil	mycophenolate mofetil
51079-721	Mycophenolate Mofetil	Mycophenolate Mofetil
51079-379	Mycophenolate Mofetil	Mycophenolate Mofetil
55154-5382	Mycophenolate Mofetil	Mycophenolate Mofetil
55154-6262	Mycophenolate Mofetil	Mycophenolate Mofetil
60429-059	Mycophenolate Mofetil	Mycophenolate Mofetil
60429-070	Mycophenolate Mofetil	Mycophenolate Mofetil
0378-2250	Mycophenolate Mofetil	Mycophenolate Mofetil
0378-4472	Mycophenolate Mofetil	Mycophenolate Mofetil
64380-726	Mycophenolate mofetil	Mycophenolate mofetil
64380-725	Mycophenolate mofetil	Mycophenolate mofetil
65841-681	Mycophenolate Mofetil	Mycophenolate Mofetil
65841-680	Mycophenolate Mofetil	Mycophenolate Mofetil
66689-307	Mycophenolate Mofetil	Mycophenolate Mofetil
50090-4275	Mycophenolate Mofetil	Mycophenolate Mofetil
70748-186	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL
0004-0259	CellCept	Mycophenolate Mofetil
0004-0260	CellCept	Mycophenolate Mofetil
0004-0261	CellCept	Mycophenolate Mofetil