FDA.reportPublic FDA data

MYCOPHENOLIC ACID

Product NDC
67877-426
11-digit product format
678770426
Labeler code
67877
Product ID
67877-426_27fbf61b-de1e-479a-9d04-6dc1d48f3148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLIC ACID
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208315
Marketing category
ANDA
Marketing start
2021-09-24
Substance
MYCOPHENOLATE SODIUM
Active strength
180 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MYCOPHENOLIC ACID
Listing expiration
2027-12-31

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
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-426-05MYCOPHENOLIC ACID500 in 1 BOTTLETABLET, DELAYED RELEASE50016
67877-426-12MYCOPHENOLIC ACID120 in 1 BOTTLETABLET, DELAYED RELEASE12016
67877-426-33MYCOPHENOLIC ACID10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1016
67877-426-38MYCOPHENOLIC ACID10 in 1 CARTONTABLET, DELAYED RELEASE1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-426-12EA - Each67877-42639c5aa5b-1253-4d4c-9e6d-8fe55b532dba12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-426MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC]11Current NDC, Legacy NDC, 4 package rows20230329_2d9975e1-baee-4b0c-83de-8a0a92c5d075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN2d9975e1-baee-4b0c-83de-8a0a92c5d07516
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN2d9975e1-baee-4b0c-83de-8a0a92c5d07516
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD2d9975e1-baee-4b0c-83de-8a0a92c5d07516
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD2d9975e1-baee-4b0c-83de-8a0a92c5d07516
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY2d9975e1-baee-4b0c-83de-8a0a92c5d07516
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY2d9975e1-baee-4b0c-83de-8a0a92c5d07516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-426-0567877042605500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-05) 2021-09-240000-00-00NoNoCurrent
67877-426-1267877042612120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-12) 2021-09-240000-00-00NoNoCurrent
67877-426-336787704263310 in 1 BLISTER PACKHistorical
67877-426-386787704263810 BLISTER PACK in 1 CARTON (67877-426-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-426-33) 10 blister pack2021-09-240000-00-00NoNoCurrent