NDC 45963-456

Deferasirox

Deferasirox

Deferasirox is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Deferasirox.

Product ID45963-456_4e679429-d272-48cf-a5ec-cc9dae2a847c
NDC45963-456
Product TypeHuman Prescription Drug
Proprietary NameDeferasirox
Generic NameDeferasirox
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2019-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA203560
Labeler NameActavis Pharma, Inc.
Substance NameDEFERASIROX
Active Ingredient Strength500 mg/1
Pharm ClassesIron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 45963-456-30

30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-456-30)
Marketing Start Date2019-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-456-30 [45963045630]

Deferasirox TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA203560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-22

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX500 mg/1

OpenFDA Data

SPL SET ID:ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597772
  • 597770
  • 597768
  • UPC Code
  • 0345963455307
  • 0345963456304
  • Pharmacological Class

    • Iron Chelating Activity [MoA]
    • Iron Chelator [EPC]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Deferasirox" or generic name "Deferasirox"

    NDCBrand NameGeneric Name
    45963-454DeferasiroxDeferasirox
    45963-456DeferasiroxDeferasirox
    45963-455DeferasiroxDeferasirox
    46708-326DeferasiroxDeferasirox
    46708-410DEFERASIROXDEFERASIROX
    46708-325DeferasiroxDeferasirox
    46708-324DeferasiroxDeferasirox
    46708-412DEFERASIROXDEFERASIROX
    62332-326DeferasiroxDeferasirox
    62332-324DeferasiroxDeferasirox
    62332-325DeferasiroxDeferasirox
    62332-410DEFERASIROXDEFERASIROX
    62332-412DEFERASIROXDEFERASIROX
    67877-551DeferasiroxDeferasirox
    67877-550DeferasiroxDeferasirox
    67877-549DeferasiroxDeferasirox
    69539-023DeferasiroxDeferasirox
    69539-073DeferasiroxDeferasirox
    69539-022DeferasiroxDeferasirox
    69539-075DeferasiroxDeferasirox
    69539-021DeferasiroxDeferasirox
    70710-1277deferasiroxdeferasirox
    70710-1275deferasiroxdeferasirox
    43598-851DeferasiroxDeferasirox
    43598-855DeferasiroxDeferasirox
    43598-856DeferasiroxDeferasirox
    43598-853DeferasiroxDeferasirox
    43598-854DeferasiroxDeferasirox
    62756-569deferasiroxdeferasirox
    62756-570deferasiroxdeferasirox
    62756-568deferasiroxdeferasirox
    69452-159DeferasiroxDeferasirox
    69452-161DeferasiroxDeferasirox
    69452-160DeferasiroxDeferasirox
    70771-1471deferasiroxdeferasirox
    70771-1473deferasiroxdeferasirox
    0093-3515DeferasiroxDeferasirox
    0093-3517DeferasiroxDeferasirox
    0591-3853DeferasiroxDeferasirox
    16714-995deferasiroxdeferasirox
    16714-993deferasiroxdeferasirox
    0078-0468Exjadedeferasirox
    0078-0469Exjadedeferasirox
    0078-0470Exjadedeferasirox
    0078-0654Jadenudeferasirox
    0078-0655Jadenudeferasirox
    0078-0656Jadenudeferasirox

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.