FDA.reportPublic FDA data

Fluorouracil

Product NDC
68001-524
11-digit product format
680010524
Labeler code
68001
Product ID
68001-524_4bbe764b-4bfd-3862-e063-6394a90a7cc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorouracil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA210123
Marketing category
ANDA
Marketing start
2022-02-18
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-524-28Fluorouracil10 mL in 1 VIALINJECTION, SOLUTION105
68001-524-29Fluorouracil20 mL in 1 VIALINJECTION, SOLUTION205
68001-524-30Fluorouracil10 in 1 CARTONINJECTION, SOLUTION105
68001-524-31Fluorouracil10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-524-28ML - Milliliter68001-5244db6f691-cca3-45de-949d-5acb99afc5d312022-07-06
68001-524-29ML - Milliliter68001-52471527c0e-1207-4bd1-be02-699b441ce60012022-07-06
68001-524-30ML - Milliliter68001-5247056e35e-7df2-46e9-9a53-67cd4e46094b12022-07-06
68001-524-31ML - Milliliter68001-524effd51c6-c00a-4e69-9c6c-45bc5b1a3ce212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-524FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 4 package rows20250114_9c42eeff-ab0c-4820-94d7-e1a3df9fda74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791736fluorouracil 1 GM in 20 ML InjectionPSN9c42eeff-ab0c-4820-94d7-e1a3df9fda745
1791701fluorouracil 500 MG in 10 ML InjectionPSN9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179170110 ML fluorouracil 50 MG/ML InjectionSCD9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179173620 ML fluorouracil 50 MG/ML InjectionSCD9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179170110 ML 5-5-fluorouracil 50 MG/ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179170110 ML 5-FU 50 MG/ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179173620 ML 5-5-fluorouracil 50 MG/ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745
179173620 ML 5-FU 50 MG/ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745
1791736fluorouracil 1 GM per 20 ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745
1791701fluorouracil 500 MG per 10 ML InjectionSY9c42eeff-ab0c-4820-94d7-e1a3df9fda745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-524-286800105242810 mL in 1 VIAL10 mlHistorical
68001-524-296800105242920 mL in 1 VIAL20 mlHistorical
68001-524-306800105243010 VIAL in 1 CARTON (68001-524-30) / 10 mL in 1 VIAL (68001-524-28) 10 vial2022-02-180000-00-00NoNoCurrent
68001-524-316800105243110 VIAL in 1 CARTON (68001-524-31) / 20 mL in 1 VIAL (68001-524-29) 10 vial2022-02-180000-00-00NoNoCurrent