NDC 69238-1594

Sirolimus

Sirolimus

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

Product ID69238-1594_c7601815-f5d5-42d1-9ba3-959706f33ccc
NDC69238-1594
Product TypeHuman Prescription Drug
Proprietary NameSirolimus
Generic NameSirolimus
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-10-25
Marketing CategoryANDA / ANDA
Application NumberANDA211212
Labeler NameAmneal Pharmaceuticals NY LLC
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 Through2020-12-31

Packaging

NDC 69238-1594-3

1 CARTON in 1 KIT (69238-1594-3) > 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) > 60 mL in 1 BOTTLE, GLASS
Marketing Start Date2019-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1594-3 [69238159403]

Sirolimus SOLUTION
Marketing CategoryANDA
Application NumberANDA211212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-25

NDC 69238-1594-6 [69238159406]

Sirolimus SOLUTION
Marketing CategoryANDA
Application NumberANDA211212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-25

Drug Details

Active Ingredients

IngredientStrength
SIROLIMUS1 mg/mL

Pharmacological Class

  • Decreased Immunologic Activity [PE]
  • mTOR Inhibitor Immunosuppressant [EPC]
  • mTOR Inhibitors [MoA]
  • Kinase Inhibitor [EPC]
  • Protein Kinase Inhibitors [MoA]

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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