FDA.reportPublic FDA data

fenofibrate

Product NDC
27241-116
11-digit product format
272410116
Labeler code
27241
Product ID
27241-116_698b59bf-d672-4ea4-8f3d-dcaee5329a39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA210138
Marketing category
ANDA
Marketing start
2018-07-20
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE54 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287, 351133

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-116-03fenofibrate90 in 1 BOTTLETABLET9015
27241-116-05fenofibrate500 in 1 BOTTLETABLET50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-116-03EA - Each27241-116ca4f54ed-a048-4d05-8854-4a1f29d2ae5512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-116FENOFIBRATE TABLET [AJANTA PHARMA USA INC.]14Current NDC, Legacy NDC, 2 package rows20241207_eb400ea7-bbd8-440b-b8be-082121621408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNeb400ea7-bbd8-440b-b8be-08212162140815
351133fenofibrate 54 MG Oral TabletPSNeb400ea7-bbd8-440b-b8be-08212162140815
349287fenofibrate 160 MG Oral TabletSCDeb400ea7-bbd8-440b-b8be-08212162140815
351133fenofibrate 54 MG Oral TabletSCDeb400ea7-bbd8-440b-b8be-08212162140815
351133fenofibrate 54 MG Oral TabletPSN58f0d475-24dc-4f93-aa40-3882b724b70f9
351133fenofibrate 54 MG Oral TabletSCD58f0d475-24dc-4f93-aa40-3882b724b70f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-116-032724101160390 TABLET in 1 BOTTLE (27241-116-03) 90 tablet2018-07-200000-00-00NoNoCurrent
27241-116-0527241011605500 TABLET in 1 BOTTLE (27241-116-05) 500 tablet2018-07-200000-00-00NoNoCurrent