Fenofibric Acid

Product NDC
68134-601
11-digit product format
681340601
Labeler code
68134
Product ID
68134-601_000114da-959d-4159-bd00-22d9b7faad4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
TABLET
Route
ORAL
Labeler
Palmetto Pharmaceuticals, Inc
Application
NDA022418
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-10-07
Marketing end
0000-00-00
Substance
FENOFIBRIC ACID
Active strength
35 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68134-601-30Fenofibric Acid30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68134-601-30EA - Each68134-601a5ebdebe-f967-4e8c-baaa-26efa6f6537712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68134-601FENOFIBRIC ACID TABLET [PALMETTO PHARMACEUTICALS, INC]1Legacy NDC, 1 package rows20210128_bb559b34-79b1-45a6-a148-38639115cd49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860880fenofibric acid 105 MG Oral TabletPSNbb559b34-79b1-45a6-a148-38639115cd491
860886fenofibric acid 35 MG Oral TabletPSNbb559b34-79b1-45a6-a148-38639115cd491
860880fenofibric acid 105 MG Oral TabletSCDbb559b34-79b1-45a6-a148-38639115cd491
860886fenofibric acid 35 MG Oral TabletSCDbb559b34-79b1-45a6-a148-38639115cd491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68134-601-306813406013030 TABLET in 1 BOTTLE, PLASTIC (68134-601-30) 30 tablet2020-10-070000-00-00NoNoCurrent