66658-110 : Orfadin 10 mg Oral Capsule


NDC66658-110
Labeler: Swedish Orphan Biovitrum Ab (Publ)
Product Type: Human Prescription Drug
Drug Name:  Orfadin
Dosage Form: Oral Capsule
Application #: NDA021232
Rev. Date: 


Appearance:


Markings: NTBC;10;mg
Shapes:  Capsule
Colors:  White
Size (mm): 16
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 66658-110-60: 1 BOTTLE, PLASTIC IN 1 CARTON (66658‑110‑60) > 60 CAPSULE IN 1 BOTTLE, PLASTIC

Active Ingredients:

  • Nitisinone

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Starch, Corn
  • Gelatin
  • Titanium Dioxide

Pharmaceutical Classes:

  • Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]
  • Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 66658-102 Orfadin 2 mg Oral Capsule by Swedish Orphan Biovitrum Ab (Publ)
  • 66658-105 Orfadin 5 mg Oral Capsule by Swedish Orphan Biovitrum Ab (Publ)
  • 66658-120 Orfadin 20 mg Oral Capsule by Swedish Orphan Biovitrum Ab (Publ)
  • 66658-204 Orfadin 4 mg/ml Oral Suspension by Swedish Orphan Biovitrum Ab (Publ)
  • 66621-1002 Orfadin 2 mg Oral Capsule by Rare Disease Therapeutics, Inc.
  • 66621-1005 Orfadin (Nitisinone 5 mg) by Rare Disease Therapeutics, Inc.
  • 66621-1010 Orfadin 10 mg Oral Capsule by Rare Disease Therapeutics, Inc.

NDC QR Code

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NDC 66658-110 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.