NDC 69844-023

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 Graviti Pharmaceuticals Private Limited. The primary component is Fenofibric Acid.

Product ID69844-023_3413a8cc-557c-4a07-8789-577b77967040
NDC69844-023
Product TypeHuman Prescription Drug
Proprietary NameFENOFIBRIC ACID DELAYED-RELEASE
Generic NameFenofibric Acid
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-07-18
Marketing CategoryANDA / ANDA
Application NumberANDA211626
Labeler NameGraviti Pharmaceuticals Private Limited
Substance NameFENOFIBRIC ACID
Active Ingredient Strength135 mg/1
Pharm ClassesPeroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69844-023-01

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-01)
Marketing Start Date2019-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69844-023-03 [69844002303]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA211626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

NDC 69844-023-01 [69844002301]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA211626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

NDC 69844-023-02 [69844002302]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA211626
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

Drug Details

Active Ingredients

IngredientStrength
FENOFIBRIC ACID135 mg/1

OpenFDA Data

SPL SET ID:865b1149-4b66-4150-a023-8448b2c05cd7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828373
  • 828379
    • UPC Code
  • 0369844022013

    • Pharmacological Class

    • Peroxisome Proliferator Receptor alpha Agonist [EPC]
    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    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.