INLYTA

Product NDC
0069-0145
11-digit product format
000690145
Labeler code
0069
Product ID
0069-0145_4382adc1-c177-44e4-988f-3f89ffecb676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
axitinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA202324
Marketing category
NDA
Marketing start
2012-01-27
Substance
AXITINIB
Active strength
1 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Receptor Tyrosine Kinase 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
INLYTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AXITINIB1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC9LVQ0YUXG
Rxcui1243004, 1243010, 1243012, 1243014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97949b4c-1118-2297-7418-fedd1057c807Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0145-01INLYTA180 in 1 BOTTLETABLET, FILM COATED18024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0145-01EA - Each0069-0145e131dc70-c75a-457e-a8ff-afacd24dd2b912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0145INLYTA (AXITINIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]24Current NDC, Legacy NDC, 1 package rows20250221_84137882-e000-47da-bd5b-fa76ab3c76f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243004axitinib 1 MG Oral TabletPSN84137882-e000-47da-bd5b-fa76ab3c76f924
1243012axitinib 5 MG Oral TabletPSN84137882-e000-47da-bd5b-fa76ab3c76f924
1243010Inlyta 1 MG Oral TabletPSN84137882-e000-47da-bd5b-fa76ab3c76f924
1243014Inlyta 5 MG Oral TabletPSN84137882-e000-47da-bd5b-fa76ab3c76f924
1243010axitinib 1 MG Oral Tablet [Inlyta]SBD84137882-e000-47da-bd5b-fa76ab3c76f924
1243014axitinib 5 MG Oral Tablet [Inlyta]SBD84137882-e000-47da-bd5b-fa76ab3c76f924
1243004axitinib 1 MG Oral TabletSCD84137882-e000-47da-bd5b-fa76ab3c76f924
1243012axitinib 5 MG Oral TabletSCD84137882-e000-47da-bd5b-fa76ab3c76f924
1243010Inlyta 1 MG Oral TabletSY84137882-e000-47da-bd5b-fa76ab3c76f924
1243014Inlyta 5 MG Oral TabletSY84137882-e000-47da-bd5b-fa76ab3c76f924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0145-0100069014501180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01) 2012-01-270000-00-00NoNoCurrent