FDA.reportPublic FDA data

MYCOPHENOLIC ACID

Product NDC
67877-929
11-digit product format
678770929
Labeler code
67877
Product ID
67877-929_8617bd03-6da7-48ca-b430-6dfc38f19e2b
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
2026-04-21
Substance
MYCOPHENOLATE SODIUM
Active strength
360 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 SODIUM360 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
67877-929-05MYCOPHENOLIC ACID500 in 1 BOTTLETABLET, DELAYED RELEASE5001
67877-929-12MYCOPHENOLIC ACID120 in 1 BOTTLETABLET, DELAYED RELEASE1201
67877-929-33MYCOPHENOLIC ACID10 in 1 BLISTER PACKTABLET, DELAYED RELEASE101
67877-929-38MYCOPHENOLIC ACID10 in 1 CARTONTABLET, DELAYED RELEASE101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN8617bd03-6da7-48ca-b430-6dfc38f19e2b1
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN8617bd03-6da7-48ca-b430-6dfc38f19e2b1
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD8617bd03-6da7-48ca-b430-6dfc38f19e2b1
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD8617bd03-6da7-48ca-b430-6dfc38f19e2b1
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY8617bd03-6da7-48ca-b430-6dfc38f19e2b1
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY8617bd03-6da7-48ca-b430-6dfc38f19e2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-929-0567877092905500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-929-05) 2026-04-21NoNoHistorical
67877-929-1267877092912120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-929-12) 2026-04-21NoNoHistorical
67877-929-336787709293310 in 1 BLISTER PACKHistorical
67877-929-386787709293810 BLISTER PACK in 1 CARTON (67877-929-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-929-33) 10 blister pack2026-04-21NoNoHistorical