sorafenib

Product NDC
51407-760
11-digit product format
514070760
Labeler code
51407
Product ID
51407-760_4876659e-ec52-fda6-e063-6294a90a40d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sorafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209050
Marketing category
ANDA
Marketing start
2022-11-09
Substance
SORAFENIB
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
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
51407-760-12sorafenib120 in 1 BOTTLETABLET, FILM COATED1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-760-12EA - Each51407-760b4125f9e-40a5-4419-972f-58f2f9e36d3712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-760SORAFENIB TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, 1 package rows20241213_faa9d847-2cd5-6538-e053-6394a90aa92b.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 startSampleExclude flagStatus
51407-760-1251407076012120 TABLET, FILM COATED in 1 BOTTLE (51407-760-12) 2023-04-14NoNoHistorical