NDC 70518-3546

Sirolimus

Sirolimus

Sirolimus is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Sirolimus.

Product ID70518-3546_e9e98a8f-4d12-4311-e053-2a95a90a0bd8
NDC70518-3546
Product TypeHuman Prescription Drug
Proprietary NameSirolimus
Generic NameSirolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-09-30
Marketing CategoryANDA /
Application NumberANDA214753
Labeler NameREMEDYREPACK INC.
Substance NameSIROLIMUS
Active Ingredient Strength1 mg/1
Pharm ClassesDecreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70518-3546-0

100 POUCH in 1 BOX (70518-3546-0) > 1 TABLET in 1 POUCH (70518-3546-1)
Marketing Start Date2022-09-30
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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