NDC 13668-658

Sirolimus

Sirolimus

Sirolimus is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Sirolimus.

Product ID13668-658_d4b251f6-5378-2fc1-e053-2a95a90a73bf
NDC13668-658
Product TypeHuman Prescription Drug
Proprietary NameSirolimus
Generic NameSirolimus
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2021-12-27
Marketing CategoryANDA /
Application NumberANDA215016
Labeler NameTorrent pharmaceuticals limited
Substance NameSIROLIMUS
Active Ingredient Strength1 mg/mL
Pharm ClassesDecreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 13668-658-87

1 CARTON in 1 KIT (13668-658-87) > 1 BOTTLE, GLASS in 1 CARTON > 60 mL in 1 BOTTLE, GLASS (13668-658-13)
Marketing Start Date2021-12-27
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0904-7147sirolimussirolimus
0904-7248SirolimusSirolimus
13668-658SirolimusSirolimus
16714-187sirolimussirolimus
16714-188sirolimussirolimus
16714-189sirolimussirolimus
68084-956SirolimusSirolimus
68084-915SirolimusSirolimus
68382-520sirolimussirolimus
70954-075SirolimusSirolimus
50268-718SirolimusSirolimus
55111-654SirolimusSirolimus
55111-653SirolimusSirolimus
59762-1002SirolimusSirolimus
59762-1003SirolimusSirolimus
59762-1001SirolimusSirolimus
65841-771sirolimussirolimus
66689-347SirolimusSirolimus
59762-1205SirolimusSirolimus
69238-1594SirolimusSirolimus
60505-6197SirolimusSirolimus
68462-682sirolimussirolimus
68462-684sirolimussirolimus
68462-683sirolimussirolimus
0008-1030RapamuneSIROLIMUS
0008-1040RapamuneSIROLIMUS
0008-1041RapamuneSIROLIMUS
0008-1042RapamuneSIROLIMUS
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