FDA.reportPublic FDA data

fluorouracil

Product NDC
25021-215
11-digit product format
250210215
Labeler code
25021
Product ID
25021-215_223c5d8d-c064-4a0a-8490-b1c4aa0e706d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorouracil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA203609
Marketing category
ANDA
Marketing start
2016-09-15
Substance
FLUOROURACIL
Active strength
50 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluorouracil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOROURACIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3P01618RT
Rxcui239177

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dc9482d-9b87-4471-9708-4f1b4585846bProduct name220250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cbProduct name520250630
dc0d2364-4811-4665-a3ee-7ed8c7301465Product name220171219
62fb8671-1693-49d8-8aab-0c1bfdd6794eProduct name120151005
878ca466-81fd-9d24-1349-31baf36065c6Product name220150506
630d1bc2-ae6b-fd31-1264-c4733e788193Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-215-98fluorouracil1 in 1 CARTONINJECTION, SOLUTION19
25021-215-98fluorouracil50 mL in 1 BOTTLEINJECTION, SOLUTION509
25021-215-99fluorouracil100 mL in 1 BOTTLEINJECTION, SOLUTION1009
25021-215-99fluorouracil1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-215-98ML - Milliliter25021-215d6310bdd-544e-40c7-945c-00d04d04937812016-10-06
25021-215-99ML - Milliliter25021-21585936e14-3fd5-46b3-ab1f-36b4f8bd7c4712016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-215FLUOROURACIL INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]8Current NDC, Legacy NDC, 4 package rows20240507_37e35e8c-5d51-413b-a3a0-b72a18caaf65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239177fluorouracil 50 MG/ML Injectable SolutionPSN37e35e8c-5d51-413b-a3a0-b72a18caaf659
239177fluorouracil 50 MG/ML Injectable SolutionSCD37e35e8c-5d51-413b-a3a0-b72a18caaf659
2391775-5-fluorouracil 50 MG/ML Injectable SolutionSY37e35e8c-5d51-413b-a3a0-b72a18caaf659
2391775-FU 50 MG/ML Injectable SolutionSY37e35e8c-5d51-413b-a3a0-b72a18caaf659
239177fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable SolutionSY37e35e8c-5d51-413b-a3a0-b72a18caaf659
239177fluorouracil 2.5 GM per 50 ML Injectable SolutionSY37e35e8c-5d51-413b-a3a0-b72a18caaf659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-215-98250210215981 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE1 bottle2016-09-150000-00-00NoNoCurrent
25021-215-99250210215991 BOTTLE in 1 CARTON (25021-215-99) / 100 mL in 1 BOTTLE1 bottle2016-09-150000-00-00NoNoCurrent