NDC 42658-501

Mycophenolate Mofetil

Mycophenolate Mofetil

Mycophenolate Mofetil is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hisun Pharmaceuticals Usa, Inc.. The primary component is Mycophenolate Mofetil.

• Product ID: 42658-501_5f16c773-e2f8-2d5b-e053-2a91aa0a5493
• NDC: 42658-501
• Product Type: Human Prescription Drug
• Proprietary Name: Mycophenolate Mofetil
• Generic Name: Mycophenolate Mofetil
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204077
• Labeler Name: Hisun Pharmaceuticals USA, Inc.
• Substance Name: MYCOPHENOLATE MOFETIL
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Antimetabolite Immunosuppressant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42658-501-07

500 CAPSULE in 1 BOTTLE (42658-501-07)

• Marketing Start Date: 2017-11-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42658-501-06 [42658050106]

Mycophenolate Mofetil CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204077
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-13
• Marketing End Date: 2019-05-17

NDC 42658-501-07 [42658050107]

Mycophenolate Mofetil CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204077
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-13
• Marketing End Date: 2019-05-17

NDC 42658-501-05 [42658050105]

Mycophenolate Mofetil CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204077
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-13
• Marketing End Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
MYCOPHENOLATE MOFETIL	250 mg/1

OpenFDA Data

• SPL SET ID: 5f16c773-e359-2d5b-e053-2a91aa0a5493
• Manufacturer:
  • Hisun Pharmaceuticals USA, Inc.
• UNII:
  • 9242ECW6R0
• RxNorm Concept Unique ID - RxCUI:
  • 199058

Pharmacological Class

• 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