NDC 68254-5002

mycophenolic acid

Mycophenolic Acid

mycophenolic acid is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Concord Biotech Limited. The primary component is Mycophenolate Sodium.

Product ID68254-5002_6356ba0c-2cf2-4c66-90ff-1e07a1aa67fb
NDC68254-5002
Product TypeHuman Prescription Drug
Proprietary Namemycophenolic acid
Generic NameMycophenolic Acid
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-12-13
Marketing CategoryANDA / ANDA
Application NumberANDA211173
Labeler NameCONCORD BIOTECH LIMITED
Substance NameMYCOPHENOLATE SODIUM
Active Ingredient Strength360 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68254-5002-1

120 TABLET, DELAYED RELEASE in 1 BOTTLE (68254-5002-1)
Marketing Start Date2019-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68254-5002-2 [68254500202]

mycophenolic acid TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA211173
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-13

NDC 68254-5002-1 [68254500201]

mycophenolic acid TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA211173
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-13

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.