NDC 46708-412

DEFERASIROX

Deferasirox

DEFERASIROX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Deferasirox.

Product ID46708-412_dd9450f4-7c95-4322-8806-9820570f5aa2
NDC46708-412
Product TypeHuman Prescription Drug
Proprietary NameDEFERASIROX
Generic NameDeferasirox
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA211824
Labeler NameAlembic Pharmaceuticals Limited
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 Through2020-12-31

Packaging

NDC 46708-412-91

1000 TABLET, FILM COATED in 1 BOTTLE (46708-412-91)
Marketing Start Date2019-11-21
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX360 mg/1

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
45963-455DeferasiroxDeferasirox
45963-456DeferasiroxDeferasirox
43598-851DeferasiroxDeferasirox
43598-853DeferasiroxDeferasirox
43598-854DeferasiroxDeferasirox
43598-855DeferasiroxDeferasirox
43598-856DeferasiroxDeferasirox
46708-324DeferasiroxDeferasirox
46708-325DeferasiroxDeferasirox
46708-326DeferasiroxDeferasirox
46708-410DEFERASIROXDEFERASIROX
46708-412DEFERASIROXDEFERASIROX
62332-324DeferasiroxDeferasirox
62332-325DeferasiroxDeferasirox
62332-326DeferasiroxDeferasirox
62332-410DEFERASIROXDEFERASIROX
62332-412DEFERASIROXDEFERASIROX
67877-549DeferasiroxDeferasirox
67877-550DeferasiroxDeferasirox
67877-551DeferasiroxDeferasirox
69452-159DeferasiroxDeferasirox
69452-160DeferasiroxDeferasirox
69452-161DeferasiroxDeferasirox
69539-021DeferasiroxDeferasirox
69539-022DeferasiroxDeferasirox
69539-023DeferasiroxDeferasirox
69539-073DeferasiroxDeferasirox
69539-075DeferasiroxDeferasirox
70710-1275deferasiroxdeferasirox
70710-1277deferasiroxdeferasirox
0078-0468Exjadedeferasirox
0078-0469Exjadedeferasirox
0078-0470Exjadedeferasirox
0078-0654Jadenudeferasirox
0078-0655Jadenudeferasirox
0078-0656Jadenudeferasirox
0078-0713Jadenudeferasirox
0078-0720Jadenudeferasirox
0078-0727Jadenudeferasirox

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