NDC 69539-199

Deferasorox

Deferasirox

Deferasorox is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Deferasirox.

Product ID69539-199_40154b92-b71c-4ccc-b959-99b5c1528d25
NDC69539-199
Product TypeHuman Prescription Drug
Proprietary NameDeferasorox
Generic NameDeferasirox
Dosage FormGranule
Route of AdministrationORAL
Marketing Start Date2021-03-18
Marketing CategoryANDA /
Application NumberANDA214650
Labeler NameMSN LABORATORIES PRIVATE LIMITED
Substance NameDEFERASIROX
Active Ingredient Strength180 mg/1
Pharm ClassesCytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69539-199-30

30 PACKET in 1 CARTON (69539-199-30) > 1 GRANULE in 1 PACKET (69539-199-62)
Marketing Start Date2021-03-18
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0078-0468Exjadedeferasirox
0078-0469Exjadedeferasirox
0078-0470Exjadedeferasirox
0078-0654Jadenudeferasirox
0078-0655Jadenudeferasirox
0078-0656Jadenudeferasirox

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