mycophenolic acid

Product NDC
72888-199
11-digit product format
728880199
Labeler code
72888
Product ID
72888-199_49ed1732-f2d8-4b03-8eb3-54748ad9b994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolic acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA211173
Marketing category
ANDA
Marketing start
2023-11-10
Substance
MYCOPHENOLATE SODIUM
Active strength
180 mg/1
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
mycophenolic acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWX877SQI1G
Rxcui485020, 485023

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-199-12mycophenolic acid120 in 1 BOTTLETABLET, DELAYED RELEASE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-199-12EA - Each72888-199c0bfe19e-88b4-4dc9-aa51-72be2180530e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-199MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ADVAGEN PHARMA LIMITED]2Current NDC, 1 package rows20240319_a2c1a135-67e7-4052-bbb9-b6135d45ff75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNa2c1a135-67e7-4052-bbb9-b6135d45ff753
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNa2c1a135-67e7-4052-bbb9-b6135d45ff753
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDa2c1a135-67e7-4052-bbb9-b6135d45ff753
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDa2c1a135-67e7-4052-bbb9-b6135d45ff753
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYa2c1a135-67e7-4052-bbb9-b6135d45ff753
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYa2c1a135-67e7-4052-bbb9-b6135d45ff753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-199-1272888019912120 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-199-12) 2023-11-10NoNoCurrent