FDA.reportPublic FDA data

Fenofibrate

Product NDC
71205-949
11-digit product format
712050949
Labeler code
71205
Product ID
71205-949_7086101a-d52f-43a3-9fc3-70c2aa9487bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207803
Marketing category
ANDA
Marketing start
2020-04-23
Substance
FENOFIBRATE
Active strength
160 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fenofibrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui349287

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
71205-949-30Fenofibrate30 in 1 BOTTLETABLET, FILM COATED302
71205-949-55Fenofibrate500 in 1 BOTTLETABLET, FILM COATED5002
71205-949-60Fenofibrate60 in 1 BOTTLETABLET, FILM COATED602
71205-949-72Fenofibrate120 in 1 BOTTLETABLET, FILM COATED1202
71205-949-78Fenofibrate180 in 1 BOTTLETABLET, FILM COATED1802
71205-949-90Fenofibrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-949-30EA - Each71205-94994e5112c-e95c-4858-9a67-61cc6a7c889f12022-02-07
71205-949-55EA - Each71205-94964d44b50-d4b9-4264-aca1-e72aeeecd59b12022-02-07
71205-949-60EA - Each71205-9496bbf2590-10af-43b0-b8fb-e939cad5804e12022-02-07
71205-949-72EA - Each71205-949225c64b6-d47b-46dd-8307-f70b4041f60412022-02-07
71205-949-78EA - Each71205-949368dccc6-c935-46a0-95f1-7559559aef7212022-02-07
71205-949-90EA - Each71205-949d5692cc1-57f2-4e23-bd0e-d2e81426bef312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-949FENOFIBRATE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220331_41f0f514-1fa9-47a0-a085-a31354842f96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSN41f0f514-1fa9-47a0-a085-a31354842f962
349287fenofibrate 160 MG Oral TabletSCD41f0f514-1fa9-47a0-a085-a31354842f962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-949-307120509493030 TABLET, FILM COATED in 1 BOTTLE (71205-949-30) 2020-10-080000-00-00NoNoCurrent
71205-949-5571205094955500 TABLET, FILM COATED in 1 BOTTLE (71205-949-55) 2020-10-080000-00-00NoNoCurrent
71205-949-607120509496060 TABLET, FILM COATED in 1 BOTTLE (71205-949-60) 2020-10-080000-00-00NoNoCurrent
71205-949-7271205094972120 TABLET, FILM COATED in 1 BOTTLE (71205-949-72) 2020-10-080000-00-00NoNoCurrent
71205-949-7871205094978180 TABLET, FILM COATED in 1 BOTTLE (71205-949-78) 2020-10-080000-00-00NoNoCurrent
71205-949-907120509499090 TABLET, FILM COATED in 1 BOTTLE (71205-949-90) 2020-10-080000-00-00NoNoCurrent