FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
66689-307
11-digit product format
666890307
Labeler code
66689
Product ID
66689-307_1b2ac486-8e83-4fcf-998f-8e4f828cc406
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolate Mofetil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA210370
Marketing category
ANDA
Marketing start
2019-02-15
Substance
MYCOPHENOLATE MOFETIL
Active strength
200 mg/mL
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolate Mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui311880

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-307-08Mycophenolate Mofetil1 in 1 CARTONPOWDER, FOR SUSPENSION118
66689-307-08Mycophenolate Mofetil250 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION25018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-307-08ML - Milliliter66689-307c0e472b7-32bb-45ba-93b4-278fee1f24e612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-307MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [VISTAPHARM, LLC]17Current NDC, Legacy NDC, 2 package rows20230110_175d8b87-e06a-4c9e-b3de-378114b52274.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311880mycophenolate mofetil 200 MG in 1 mL Oral SuspensionPSN175d8b87-e06a-4c9e-b3de-378114b5227418
311880mycophenolate mofetil 200 MG/ML Oral SuspensionSCD175d8b87-e06a-4c9e-b3de-378114b5227418
311880mycophenolate mofetil 200 MG per 1 ML Oral SuspensionSY175d8b87-e06a-4c9e-b3de-378114b5227418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66689-307-08666890307081 BOTTLE, PLASTIC in 1 CARTON (66689-307-08) / 250 mL in 1 BOTTLE, PLASTIC2019-02-150000-00-00NoNoCurrent