NDC 16714-995

deferasirox

Deferasirox

deferasirox is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Northstar Rx Llc.. The primary component is Deferasirox.

Product ID16714-995_1a633bc4-a637-4dd6-b7d1-b8181858ef3d
NDC16714-995
Product TypeHuman Prescription Drug
Proprietary Namedeferasirox
Generic NameDeferasirox
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-16
Marketing CategoryANDA / ANDA
Application NumberANDA211383
Labeler NameNorthstar Rx LLC.
Substance NameDEFERASIROX
Active Ingredient Strength360 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 Through2021-12-31

Packaging

NDC 16714-995-01

30 TABLET, FILM COATED in 1 BOTTLE (16714-995-01)
Marketing Start Date2020-03-16
Marketing End Date2023-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-995-01 [16714099501]

deferasirox TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-16

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX360 mg/1

OpenFDA Data

SPL SET ID:6b2840f1-8d19-4a22-b66a-13b3d76b10d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1607792
  • 1607796
  • 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

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