FDA.reportPublic FDA data

sorafenib

Product NDC
24979-715
11-digit product format
249790715
Labeler code
24979
Product ID
24979-715_4685e399-b323-4da9-e063-6294a90af931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sorafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA209050
Marketing category
ANDA
Marketing start
2022-12-01
Substance
SORAFENIB
Active strength
200 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein 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
sorafenib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SORAFENIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9ZOQ3TZI87
Rxcui597747

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33680929-c1c0-4a67-aa2e-1f98b8efd580Product name120240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-715-04sorafenib60 in 1 BOTTLETABLET, FILM COATED6016
24979-715-44sorafenib120 in 1 BOTTLETABLET, FILM COATED12016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-715-44EA - Each24979-715ffcb9bf0-5f06-4963-942d-ab6677faf03d12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-715SORAFENIB TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]13Current NDC, Legacy NDC, 2 package rows20241208_68aa4b7f-3f13-4e73-b572-aa6c11a8429c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597747SORAfenib 200 MG Oral TabletPSNfaa9d847-2cd5-6538-e053-6394a90aa92b8
597747sorafenib 200 MG Oral TabletSCDfaa9d847-2cd5-6538-e053-6394a90aa92b8
597747sorafenib (as sorafenib tosylate) 200 MG Oral TabletSYfaa9d847-2cd5-6538-e053-6394a90aa92b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-715-042497907150460 TABLET, FILM COATED in 1 BOTTLE (24979-715-04) 2022-12-010000-00-00NoNoCurrent
24979-715-4424979071544120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44) 2022-12-010000-00-00NoNoCurrent