FDA.reportPublic FDA data

sorafenib

Product NDC
43598-458
11-digit product format
435980458
Labeler code
43598
Product ID
43598-458_b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sorafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA216073
Marketing category
ANDA
Marketing start
2022-06-08
Substance
SORAFENIB TOSYLATE
Active strength
200 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein 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
sorafenib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SORAFENIB TOSYLATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T62Q3B36J
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
43598-458-04sorafenib120 in 1 BOTTLETABLET, FILM COATED1207
43598-458-36sorafenib360 in 1 BOTTLETABLET, FILM COATED3607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-458-04EA - Each43598-45807416404-c354-4d1a-b1d9-10ead1e33b7012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-458SORAFENIB TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]6Current NDC, Legacy NDC, 2 package rows20230228_93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597747SORAfenib 200 MG Oral TabletPSN93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a67
597747sorafenib 200 MG Oral TabletSCD93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a67
597747sorafenib (as sorafenib tosylate) 200 MG Oral TabletSY93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-458-0443598045804120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04) 2022-06-080000-00-00NoNoCurrent
43598-458-3643598045836360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36) 2022-06-080000-00-00NoNoCurrent