MYCOPHENOLIC ACID

Product NDC
59651-622
11-digit product format
596510622
Labeler code
59651
Product ID
59651-622_f6e5e3de-bd8c-451a-a6f0-831b15ede576
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MYCOPHENOLIC ACID
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218603
Marketing category
ANDA
Marketing start
2024-02-27
Substance
MYCOPHENOLATE SODIUM
Active strength
360 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 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
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
59651-622-08MYCOPHENOLIC ACID120 in 1 BOTTLETABLET, DELAYED RELEASE1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-622-08EA - Each59651-622097fb5b2-e405-4bde-a81a-c58e2e57746012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-622MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20240305_5b224d7f-fecb-4531-9d27-008347777c9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN5b224d7f-fecb-4531-9d27-008347777c9d2
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN5b224d7f-fecb-4531-9d27-008347777c9d2
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD5b224d7f-fecb-4531-9d27-008347777c9d2
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD5b224d7f-fecb-4531-9d27-008347777c9d2
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY5b224d7f-fecb-4531-9d27-008347777c9d2
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY5b224d7f-fecb-4531-9d27-008347777c9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-622-0859651062208120 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-622-08) 2024-02-27NoNoHistorical