10148-201 : Miglustat 100 mg Oral Capsule


NDC: 10148-201
Labeler: Cotherix, Inc.
Product Type: Human Prescription Drug
Drug Name:  Miglustat
Dosage Form: Oral Capsule
Application #: NDA021348
Rev. Date: 


Appearance:


Markings: OGT;918;100
Shapes:  Capsule
Colors:  White
Size (mm): 14
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:

  • 10148-201-90: 6 BLISTER PACK IN 1 CARTON (10148‑201‑90) > 15 CAPSULE IN 1 BLISTER PACK (10148‑201‑15)

Active Ingredients:

  • Miglustat

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Sodium Starch Glycolate Type a Potato
  • Povidone K30
  • Magnesium Stearate
  • Gelatin, Unspecified
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • Shellac

Pharmaceutical Classes:

  • Glucosylceramide Synthase Inhibitor [EPC]
  • Glucosylceramide Synthase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 42799-708 Miglustat 100 mg Oral Capsule by Edenbridge Pharmaceuticals LLC.
  • 43975-310 Miglustat 100 mg Oral Capsule by Amerigen Pharmaceuticals Inc.
  • 51991-959 Miglustat 100 mg Oral Capsule by Breckenridge Pharmaceutical, Inc.

NDC QR Code

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NDC 10148-201 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.