70954-009 : Nitisinone 5 mg Oral Capsule


NDC: 70954-009
Labeler: Novitium Pharma LLC
Product Type: Human Prescription Drug
Drug Name:  Nitisinone
Dosage Form: Oral Capsule
Application #: ANDA211041
Rev. Date: 


Appearance:


Markings: 009;Novitium5mg
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:

  • 70954-009-20: 60 CARTON IN 1 BOTTLE (70954‑009‑20) > 1 CAPSULE IN 1 CARTON

Active Ingredients:

  • Nitisinone

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Hypromellose 2910 (5 Mpa.s)
  • Mannitol
  • Stearic Acid
  • Gelatin
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • Potassium Hydroxide
  • Propylene Glycol
  • Shellac
  • Ammonia /

Pharmaceutical Classes:

  • 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]
  • Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 70954-008 Nitisinone 2 mg Oral Capsule by Novitium Pharma LLC
  • 70954-010 Nitisinone 10 mg Oral Capsule by Novitium Pharma LLC
  • 0254-3020 Nitisinone 2 mg Oral Capsule by Par Pharmaceutical, Inc.
  • 0254-3021 Nitisinone 5 mg Oral Capsule by Par Pharmaceutical, Inc.
  • 0254-3022 Nitisinone 10 mg Oral Capsule by Par Pharmaceutical, Inc.
  • 13668-629 Nitisinone 2 mg Oral Capsule by Torrent Pharmaceuticals Limited
  • 13668-630 Nitisinone 5 mg Oral Capsule by Torrent Pharmaceuticals Limited
  • 13668-631 Nitisinone 10 mg Oral Capsule by Torrent Pharmaceuticals Limited
  • 13668-632 Nitisinone 20 mg Oral Capsule by Torrent Pharmaceuticals Limited
  • 63629-2233 Nitisinone 10 mg Oral Capsule by Bryant Ranch Prepack
  • 63629-2234 Nitisinone 2 mg Oral Capsule by Bryant Ranch Prepack
  • 63629-2235 Nitisinone 5 mg Oral Capsule by Bryant Ranch Prepack
  • 70505-202 Nitisinone 2 mg Oral Capsule by Analog Pharma
  • 70505-205 Nitisinone 5 mg Oral Capsule by Analog Pharma
  • 70505-210 Nitisinone 10 mg Oral Capsule by Analog Pharma
  • 70505-220 Nitisinone 20 mg Oral Capsule by Analog Pharma
  • 71863-119 Nitisinone 2 mg Oral Capsule by Eton Pharmaceuticals, Inc.
  • 71863-120 Nitisinone 5 mg Oral Capsule by Eton Pharmaceuticals, Inc.
  • 71863-121 Nitisinone 10 mg Oral Capsule by Eton Pharmaceuticals, Inc.
  • 71863-122 Nitisinone 20 mg Oral Capsule by Eton Pharmaceuticals, Inc.

NDC QR Code

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NDC 70954-009 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.