NDC 0378-4201

Mycophenolic Acid

Mycophenolic Acid

Mycophenolic Acid is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Mycophenolic Acid.

Product ID0378-4201_75783cee-b6a7-46fb-b605-8973200a3eb1
NDC0378-4201
Product TypeHuman Prescription Drug
Proprietary NameMycophenolic Acid
Generic NameMycophenolic Acid
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-01-08
Marketing End Date2023-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA091248
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMYCOPHENOLIC ACID
Active Ingredient Strength180 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-4201-78

120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4201-78)
Marketing Start Date2014-01-08
Marketing End Date2023-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4201-78 [00378420178]

Mycophenolic Acid TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091248
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-08

NDC 0378-4201-24 [00378420124]

Mycophenolic Acid TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091248
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-08
Marketing End Date2015-03-03

Drug Details

Pharmacological Class

  • Antimetabolite Immunosuppressant [EPC]

NDC Crossover Matching brand name "Mycophenolic Acid" or generic name "Mycophenolic Acid"

NDCBrand NameGeneric Name
0093-7031Mycophenolic AcidMycophenolic Acid
0093-7032Mycophenolic AcidMycophenolic Acid
0378-4201Mycophenolic AcidMycophenolic Acid
0378-4202Mycophenolic AcidMycophenolic Acid
0904-6785Mycophenolic AcidMycophenolic Acid
0904-6786Mycophenolic AcidMycophenolic Acid
16729-189Mycophenolic AcidMycophenolic Acid
16729-261Mycophenolic AcidMycophenolic Acid
24979-160mycophenolic acidmycophenolic acid
24979-161mycophenolic acidmycophenolic acid
50268-559Mycophenolic AcidMycophenolic Acid
68084-918Mycophenolic AcidMycophenolic Acid
68084-907Mycophenolic AcidMycophenolic Acid
51079-508Mycophenolic AcidMycophenolic Acid
51079-509Mycophenolic AcidMycophenolic Acid
60429-016Mycophenolic AcidMycophenolic Acid
60505-2966Mycophenolic AcidMycophenolic Acid
60505-2965Mycophenolic AcidMycophenolic Acid
60429-017Mycophenolic AcidMycophenolic Acid
68254-5001mycophenolic acidmycophenolic acid
68254-5002mycophenolic acidmycophenolic acid
70748-217mycophenolic acidmycophenolic acid
70748-218mycophenolic acidmycophenolic acid
50268-560Mycophenolic AcidMycophenolic Acid
0078-0385Myforticmycophenolic acid
0078-0386Myforticmycophenolic acid

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