NDC 68462-494

deferasirox

Deferasirox

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

Product ID68462-494_20a2077b-0dad-4cc4-82ac-86e066263920
NDC68462-494
Product TypeHuman Prescription Drug
Proprietary Namedeferasirox
Generic NameDeferasirox
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2020-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA209433
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameDEFERASIROX
Active Ingredient Strength125 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 68462-494-30

30 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-30)
Marketing Start Date2020-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-494-30 [68462049430]

deferasirox TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA209433
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-06

NDC 68462-494-90 [68462049490]

deferasirox TABLET, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA209433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-06

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX125 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
45963-456DeferasiroxDeferasirox
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.