FDA.reportPublic FDA data

sirolimus

Product NDC
65841-771
11-digit product format
658410771
Labeler code
65841
Product ID
65841-771_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sirolimus
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA201676
Marketing category
ANDA
Marketing start
2014-01-15
Substance
SIROLIMUS
Active strength
.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sirolimus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIROLIMUS.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW36ZG6FT64
Rxcui349208, 360110, 905158

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e68235d1-1e8b-9d8c-fddb-764b8b692c25Product name720250331
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9344cc31-0398-4e2f-a65e-a24a0de47fc4Product name120230103
741e13fe-61d8-4a4c-8c27-eb206b28f1bfProduct name120220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-771-01sirolimus100 in 1 BOTTLETABLET, FILM COATED10011
65841-771-05sirolimus500 in 1 BOTTLETABLET, FILM COATED50011
65841-771-06sirolimus30 in 1 BOTTLETABLET, FILM COATED3011
65841-771-10sirolimus1000 in 1 BOTTLETABLET, FILM COATED100011
65841-771-16sirolimus90 in 1 BOTTLETABLET, FILM COATED9011
65841-771-30sirolimus10 in 1 BLISTER PACKTABLET, FILM COATED1011
65841-771-77sirolimus10 in 1 CARTONTABLET, FILM COATED1011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIROLIMUSACTIVE INGREDIENTW36ZG6FT64SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
SIROLIMUSACTIVE MOIETYW36ZG6FT64SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
GLYCERYL MONOOLEATEINACTIVE INGREDIENT4PC054V79PSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ESIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
SUCROSEINACTIVE INGREDIENTC151H8M554SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1USIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-771SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 7 package rows20230928_82562b68-224d-482a-b399-a89b81d5eb31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905158sirolimus 0.5 MG Oral TabletPSN82562b68-224d-482a-b399-a89b81d5eb3111
349208sirolimus 1 MG Oral TabletPSN82562b68-224d-482a-b399-a89b81d5eb3111
360110sirolimus 2 MG Oral TabletPSN82562b68-224d-482a-b399-a89b81d5eb3111
905158sirolimus 0.5 MG Oral TabletSCD82562b68-224d-482a-b399-a89b81d5eb3111
349208sirolimus 1 MG Oral TabletSCD82562b68-224d-482a-b399-a89b81d5eb3111
360110sirolimus 2 MG Oral TabletSCD82562b68-224d-482a-b399-a89b81d5eb3111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-771-0165841077101100 TABLET, FILM COATED in 1 BOTTLE (65841-771-01) 2014-01-150000-00-00NoNoCurrent
65841-771-0565841077105500 TABLET, FILM COATED in 1 BOTTLE (65841-771-05) 2014-01-15NoNoHistorical
65841-771-066584107710630 TABLET, FILM COATED in 1 BOTTLE (65841-771-06) 2014-01-15NoNoHistorical
65841-771-10658410771101000 TABLET, FILM COATED in 1 BOTTLE (65841-771-10) 2014-01-15NoNoHistorical
65841-771-166584107711690 TABLET, FILM COATED in 1 BOTTLE (65841-771-16) 2014-01-15NoNoHistorical
65841-771-306584107713010 in 1 BLISTER PACKHistorical
65841-771-776584107717710 BLISTER PACK in 1 CARTON (65841-771-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-771-30) 10 blister pack2014-01-15NoNoHistorical