FDA.reportPublic FDA data

Fenofibric acid

Product NDC
42571-347
11-digit product format
425710347
Labeler code
42571
Product ID
42571-347_38613bf4-bb82-1834-e063-6294a90ab048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA213450
Marketing category
ANDA
Marketing start
2020-09-01
Substance
FENOFIBRIC ACID
Active strength
45 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
Fenofibric acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRIC ACID45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBGF9MN2HU1
Rxcui828373, 828379

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-347-30Fenofibric acid30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
42571-347-90Fenofibric acid90 in 1 BOTTLECAPSULE, DELAYED RELEASE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-347FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 2 package rows20221128_9c87ff52-04d5-4833-8cec-c33bb646b7c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828373fenofibric acid 135 MG Delayed Release Oral CapsulePSN9c87ff52-04d5-4833-8cec-c33bb646b7c79
828379fenofibric acid 45 MG Delayed Release Oral CapsulePSN9c87ff52-04d5-4833-8cec-c33bb646b7c79
828373fenofibric acid 135 MG Delayed Release Oral CapsuleSCD9c87ff52-04d5-4833-8cec-c33bb646b7c79
828379fenofibric acid 45 MG Delayed Release Oral CapsuleSCD9c87ff52-04d5-4833-8cec-c33bb646b7c79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42571-347-304257103473030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-347-30) 2020-09-010000-00-00NoNoCurrent
42571-347-904257103479090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-347-90) 2020-09-010000-00-00NoNoCurrent