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Kalydeco
Kalydeco - 51167-200-01 - (ivacaftor)
Drug Information of Kalydeco
| Product NDC: | 51167-200 |
| Proprietary Name: | Kalydeco |
| Non Proprietary Name: | ivacaftor |
| Active Ingredient(s): | 150 mg/1 & nbsp; ivacaftor |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Kalydeco
| Product NDC: | 51167-200 |
| Labeler Name: | Vertex Pharmaceuticals Incorporated |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203188 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120131 |
Package Information of Kalydeco
| Package NDC: | 51167-200-01 |
| Package Description: | 4 BLISTER PACK in 1 CARTON (51167-200-01) > 14 TABLET, FILM COATED in 1 BLISTER PACK |
NDC Information of Kalydeco
| NDC Code | 51167-200-01 |
| Proprietary Name | Kalydeco |
| Package Description | 4 BLISTER PACK in 1 CARTON (51167-200-01) > 14 TABLET, FILM COATED in 1 BLISTER PACK |
| Product NDC | 51167-200 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ivacaftor |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20120131 |
| Marketing Category Name | NDA |
| Labeler Name | Vertex Pharmaceuticals Incorporated |
| Substance Name | IVACAFTOR |
| Strength Number | 150 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA] |
