NDC 24979-109

Fenofibric Acid Delayed-Release

Fenofibric Acid

Fenofibric Acid Delayed-Release is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Twi Pharmaceuticals, Inc.. The primary component is Choline Fenofibrate.

Product ID24979-109_bfe87110-ea45-4b08-873f-e75115c5ecb6
NDC24979-109
Product TypeHuman Prescription Drug
Proprietary NameFenofibric Acid Delayed-Release
Generic NameFenofibric Acid
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA210469
Labeler NameTWi Pharmaceuticals, Inc.
Substance NameCHOLINE FENOFIBRATE
Active Ingredient Strength45 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 24979-109-07

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-109-07)
Marketing Start Date2020-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24979-109-07 [24979010907]

Fenofibric Acid Delayed-Release CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA210469
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

Drug Details

NDC Crossover Matching brand name "Fenofibric Acid Delayed-Release" or generic name "Fenofibric Acid"

NDCBrand NameGeneric Name
42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACID
42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric Acid
60429-432Fenofibric Acid Delayed-ReleaseFenofibric Acid Delayed-Release
69844-023FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACID DELAYED-RELEASE
69844-022FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACID DELAYED-RELEASE
0115-1554Fenofibric AcidFenofibric Acid
0115-1555Fenofibric AcidFenofibric Acid
0228-2838fenofibric acidfenofibric acid
0228-2839fenofibric acidfenofibric acid
0378-2589Fenofibric Acidfenofibric acid
0378-2590Fenofibric Acidfenofibric acid
10370-209Fenofibric AcidFenofibric Acid
10370-210Fenofibric AcidFenofibric Acid
24979-109Fenofibric AcidFenofibric Acid
24979-112Fenofibric AcidFenofibric Acid
13310-101FIBRICORFenofibric Acid
13310-102FIBRICORFenofibric Acid
0074-3161TrilipixFenofibric Acid
0074-3162TrilipixFenofibric Acid
0074-9189TrilipixFenofibric Acid
0074-9642TrilipixFenofibric Acid
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.