NDC 60505-4631

CycloSPORINE, Modfied

Cyclosporine

CycloSPORINE, Modfied is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Cyclosporine.

Product ID60505-4631_09917584-bea5-cb5c-ccd0-fb2bf3bf3850
NDC60505-4631
Product TypeHuman Prescription Drug
Proprietary NameCycloSPORINE, Modfied
Generic NameCyclosporine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA210721
Labeler NameApotex Corp.
Substance NameCYCLOSPORINE
Active Ingredient Strength50 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60505-4631-3

30 BLISTER PACK in 1 CARTON (60505-4631-3) > 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2019-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-4631-3 [60505463103]

CycloSPORINE, Modfied CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210721
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-05

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE50 mg/1

Pharmacological Class

  • Calcineurin Inhibitor Immunosuppressant [EPC]
  • Calcineurin Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Calcineurin Inhibitor Immunosuppressant [EPC]
  • Calcineurin Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "CycloSPORINE, Modfied" or generic name "Cyclosporine"

NDCBrand NameGeneric Name
60505-4631CycloSPORINE, ModfiedCycloSPORINE, Modfied
60505-4630CycloSPORINE, ModfiedCycloSPORINE, Modfied
60505-4632CycloSPORINE, ModfiedCycloSPORINE, Modfied
0074-3108GengrafCyclosporine
0074-3109GengrafCyclosporine
0074-7269GengrafCyclosporine
0078-0246Neoralcyclosporine
0078-0248Neoralcyclosporine
0023-9163RESTASIScyclosporine
0023-5301Restasis MultiDosecyclosporine
0078-0109Sandimmunecyclosporine
0078-0110Sandimmunecyclosporine
0078-0240Sandimmunecyclosporine
0078-0241Sandimmunecyclosporine

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