FDA.reportPublic FDA data

Fluorouracil

Product NDC
70700-188
11-digit product format
707000188
Labeler code
70700
Product ID
70700-188_4b35e0c2-3335-94bf-e063-6394a90a9454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Xiromed LLC
Application
ANDA210124
Marketing category
ANDA
Marketing start
2021-08-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70700-188-222026-01-29C16284748780-149896155-9fbf-586f-e063-e6dba90add90These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-188-22Fluorouracil1 in 1 CARTONINJECTION, SOLUTION14
70700-188-22Fluorouracil50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-188-22ML - Milliliter70700-1880cb4d0a6-cc52-4571-a2fb-10d6cf6fcb2212021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-188FLUOROURACIL INJECTION, SOLUTION [XIROMED LLC]3Current NDC, Legacy NDC, 2 package rows20210820_f4b0cae1-a2fc-2991-d663-3b729503cd1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239177fluorouracil 50 MG/ML Injectable SolutionPSNf4b0cae1-a2fc-2991-d663-3b729503cd1c4
239177fluorouracil 50 MG/ML Injectable SolutionSCDf4b0cae1-a2fc-2991-d663-3b729503cd1c4
2391775-5-fluorouracil 50 MG/ML Injectable SolutionSYf4b0cae1-a2fc-2991-d663-3b729503cd1c4
2391775-FU 50 MG/ML Injectable SolutionSYf4b0cae1-a2fc-2991-d663-3b729503cd1c4
239177fluorouracil (as fluorouracil sodium) 50 MG/ML Injectable SolutionSYf4b0cae1-a2fc-2991-d663-3b729503cd1c4
239177fluorouracil 2.5 GM per 50 ML Injectable SolutionSYf4b0cae1-a2fc-2991-d663-3b729503cd1c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-188-22707000188221 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-188-22) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-08-130000-00-00NoNoCurrent