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ORFADIN
ORFADIN - 66621-1005-6 - (nitisinone)
Drug Information of ORFADIN
| Product NDC: | 66621-1005 |
| Proprietary Name: | ORFADIN |
| Non Proprietary Name: | nitisinone |
| Active Ingredient(s): | 5 mg/1 & nbsp; nitisinone |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ORFADIN
| Product NDC: | 66621-1005 |
| Labeler Name: | Rare Disease Therapeutics, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021232 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20020118 |
Package Information of ORFADIN
| Package NDC: | 66621-1005-6 |
| Package Description: | 60 CAPSULE in 1 BOTTLE (66621-1005-6) |
NDC Information of ORFADIN
| NDC Code | 66621-1005-6 |
| Proprietary Name | ORFADIN |
| Package Description | 60 CAPSULE in 1 BOTTLE (66621-1005-6) |
| Product NDC | 66621-1005 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | nitisinone |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20020118 |
| Marketing Category Name | NDA |
| Labeler Name | Rare Disease Therapeutics, Inc. |
| Substance Name | NITISINONE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] |
