FDA.reportPublic FDA data

Mycophenolate Mofetil

Product NDC
71610-033
11-digit product format
716100033
Labeler code
71610
Product ID
71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA065521
Marketing category
ANDA
Marketing start
2015-01-06
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 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
Mycophenolate Mofetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9242ECW6R0
Rxcui200060

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
71610-033-53Mycophenolate Mofetil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
71610-033-60Mycophenolate Mofetil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
71610-033-70Mycophenolate Mofetil120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
71610-033-80Mycophenolate Mofetil180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802
71610-033-90Mycophenolate Mofetil240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2402
71610-033-92Mycophenolate Mofetil270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2702
71610-033-98Mycophenolate Mofetil540 in 1 BOTTLE, PLASTICTABLET, FILM COATED5402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-033-53EA - Each71610-033e481a311-c960-42f0-845e-8ca7e45429ea12024-04-05
71610-033-60EA - Each71610-0338f44006c-cb35-491a-9b32-bd8d3eb2345812024-04-05
71610-033-70EA - Each71610-033b20e4e85-6b5f-4ac5-8baa-be2ef0595e5f12018-04-19
71610-033-80EA - Each71610-03379b2ceda-582a-4784-a8a0-3f49a366b31012024-03-12
71610-033-90EA - Each71610-033b481ad1b-9f18-4d0e-84e4-a50e72c473a812024-04-05
71610-033-92EA - Each71610-0330534fc22-03ba-437d-b295-3a20ab788fd912024-06-10
71610-033-98EA - Each71610-0335bb1fd67-68f8-4ac9-9d7a-80f7cb89393312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-033MYCOPHENOLATE MOFETIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 7 package rows20240221_721564bc-7c0b-4418-ab49-0af362e74eb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200060mycophenolate mofetil 500 MG Oral TabletPSN721564bc-7c0b-4418-ab49-0af362e74eb72
200060mycophenolate mofetil 500 MG Oral TabletSCD721564bc-7c0b-4418-ab49-0af362e74eb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-033-537161000335360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53) 2019-07-01NoNoHistorical
71610-033-607161000336090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60) 2019-07-01NoNoHistorical
71610-033-7071610003370120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70) 2018-01-190000-00-00NoNoCurrent
71610-033-8071610003380180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80) 2019-07-01NoNoHistorical
71610-033-9071610003390240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90) 2019-07-01NoNoHistorical
71610-033-9271610003392270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92) 2019-07-01NoNoHistorical
71610-033-9871610003398540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98) 2019-07-01NoNoHistorical