FDA.reportPublic FDA data

Fluorouracil

Product NDC
70700-186
11-digit product format
707000186
Labeler code
70700
Product ID
70700-186_4b35b4f1-4de4-42de-e063-6294a90a10ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Xiromed LLC
Application
ANDA210123
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
Rxcui1791701, 1791736

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
70700-186-232026-01-29C16284748780-149896155-c21e-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
70700-186-22Fluorouracil10 mL in 1 VIALINJECTION, SOLUTION107
70700-186-23Fluorouracil10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-186FLUOROURACIL INJECTION, SOLUTION [XIROMED LLC]5Current NDC, Legacy NDC, 2 package rows20221221_19735014-c6fb-0a05-c330-2e9389c71216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791736fluorouracil 1 GM in 20 ML InjectionPSN19735014-c6fb-0a05-c330-2e9389c712167
1791701fluorouracil 500 MG in 10 ML InjectionPSN19735014-c6fb-0a05-c330-2e9389c712167
179170110 ML fluorouracil 50 MG/ML InjectionSCD19735014-c6fb-0a05-c330-2e9389c712167
179173620 ML fluorouracil 50 MG/ML InjectionSCD19735014-c6fb-0a05-c330-2e9389c712167
179170110 ML 5-5-fluorouracil 50 MG/ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167
179170110 ML 5-FU 50 MG/ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167
179173620 ML 5-5-fluorouracil 50 MG/ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167
179173620 ML 5-FU 50 MG/ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167
1791736fluorouracil 1 GM per 20 ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167
1791701fluorouracil 500 MG per 10 ML InjectionSY19735014-c6fb-0a05-c330-2e9389c712167

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-186-227070001862210 mL in 1 VIAL10 mlHistorical
70700-186-237070001862310 VIAL in 1 CARTON (70700-186-23) / 10 mL in 1 VIAL (70700-186-22) 10 vial2021-08-130000-00-00NoNoCurrent