FDA.reportPublic FDA data

TAGRISSO

Product NDC
0310-1350
11-digit product format
003101350
Labeler code
0310
Product ID
0310-1350_d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
osimertinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA208065
Marketing category
NDA
Marketing start
2015-11-13
Substance
OSIMERTINIB
Active strength
80 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Kinase 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
TAGRISSO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSIMERTINIB80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3C06JJ0Z2O
Rxcui1721565, 1721571, 1721581, 1721583

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6c14bb63-86f5-42f4-9022-4090bc2b642dProduct name120151123
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-1350-30TAGRISSO30 in 1 BOTTLETABLET, FILM COATED3036
0310-1350-95TAGRISSO1 in 1 CARTONTABLET, FILM COATED136
0310-1350-95TAGRISSO10 in 1 BLISTER PACKTABLET, FILM COATED1036
0310-1350-99TAGRISSO10 in 1 BOTTLETABLET, FILM COATED1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-1350-30EA - Each0310-1350ce96b6e0-1086-4934-b6e1-7b09e2fb401c12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OSIMERTINIBACTIVE INGREDIENT3C06JJ0Z2OTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
OSIMERTINIBACTIVE MOIETY3C06JJ0Z2OTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-1350TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]35Current NDC, Legacy NDC, 4 package rows20250228_5e81b4a7-b971-45e1-9c31-29cea8c87ce7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721565osimertinib 40 MG Oral TabletPSN5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721581osimertinib 80 MG Oral TabletPSN5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721571Tagrisso 40 MG Oral TabletPSN5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721583Tagrisso 80 MG Oral TabletPSN5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721571osimertinib 40 MG Oral Tablet [Tagrisso]SBD5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721583osimertinib 80 MG Oral Tablet [Tagrisso]SBD5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721565osimertinib 40 MG Oral TabletSCD5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721581osimertinib 80 MG Oral TabletSCD5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721565osimertinib 40 MG (as osimertinib mesylate 47.7 MG) Oral TabletSY5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721581osimertinib 80 MG (as osimertinib mesylate 95.4 mg) Oral TabletSY5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721571Tagrisso 40 MG (as osimertinib mesylate 47.7 MG) Oral TabletSY5e81b4a7-b971-45e1-9c31-29cea8c87ce736
1721583Tagrisso 80 MG (as osimertinib mesylate 95.4 MG) Oral TabletSY5e81b4a7-b971-45e1-9c31-29cea8c87ce736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-1350-300031013503030 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30) 2015-11-130000-00-00NoNoCurrent
0310-1350-95003101350951 BLISTER PACK in 1 CARTON (0310-1350-95) > 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-03-150000-00-00YesNoCurrent
0310-1350-990031013509910 TABLET, FILM COATED in 1 BOTTLE (0310-1350-99) 2026-04-19YesNoCurrent