FDA.reportPublic FDA data

Sirolimus

Product NDC
50268-718
11-digit product format
502680718
Labeler code
50268
Product ID
50268-718_4cb0eea7-6bbc-aef8-e063-6294a90a7887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sirolimus
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA201578
Marketing category
ANDA
Marketing start
2018-04-23
Substance
SIROLIMUS
Active strength
1 mg/1
Pharmacologic classes
Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIROLIMUS1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW36ZG6FT64
Rxcui349208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e68235d1-1e8b-9d8c-fddb-764b8b692c25Product name720250331
9344cc31-0398-4e2f-a65e-a24a0de47fc4Product name120230103
741e13fe-61d8-4a4c-8c27-eb206b28f1bfProduct name120220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-718-11Sirolimus1 in 1 BLISTER PACKTABLET121
50268-718-13Sirolimus30 in 1 BOXTABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-718-11EA - Each50268-7180a736b88-afbd-4200-ab4c-378ea8320f8e12018-06-11
50268-718-13EA - Each50268-718963ae3a2-e58a-4342-8648-e6e0e6f90a6012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-718SIROLIMUS TABLET [AVPAK]19Current NDC, Legacy NDC, 2 package rows20240110_6a85ad01-8144-4d9c-e053-2991aa0a4f85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349208sirolimus 1 MG Oral TabletPSN6a85ad01-8144-4d9c-e053-2991aa0a4f8521
349208sirolimus 1 MG Oral TabletSCD6a85ad01-8144-4d9c-e053-2991aa0a4f8521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-718-11502680718111 in 1 BLISTER PACKHistorical
50268-718-135026807181330 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11) 30 blister pack2018-04-230000-00-00NoNoCurrent