NDC 16714-189

sirolimus

Sirolimus

sirolimus 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 Sirolimus.

Product ID16714-189_ad39eb60-1fa0-4722-8ba1-523194921c2a
NDC16714-189
Product TypeHuman Prescription Drug
Proprietary Namesirolimus
Generic NameSirolimus
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-10-18
Marketing CategoryANDA /
Application NumberANDA208691
Labeler NameNORTHSTAR RX LLC
Substance NameSIROLIMUS
Active Ingredient Strength2 mg/1
Pharm ClassesDecreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16714-189-01

100 TABLET, FILM COATED in 1 BOTTLE (16714-189-01)
Marketing Start Date2021-10-18
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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