0245-1072 : Qudexy 50 mg Oral Capsule, Extended Release

Labeler: Upsher-smith Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Qudexy XR
Dosage Form: Oral Capsule, Extended Release
Application #: NDA205122
Rev. Date: 


Markings: UPSHER;SMITH;50mg
Shapes:  Capsule
Colors:  Yellow / Gray
Size (mm): 8
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:

  • 0245-1072-15: 500 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0245‑1072‑15)
  • 0245-1072-30: 1 BOTTLE IN 1 CARTON (0245‑1072‑30) > 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE
  • 0245-1072-90: 1 BOTTLE IN 1 CARTON (0245‑1072‑90) > 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE

Active Ingredients:

  • Topiramate

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Hypromellose 2910 (6 Mpa.s)
  • Ethylcelluloses
  • Diethyl Phthalate
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Decreased Central Nervous System Disorganized Electrical Activity [PE]
  • Cytochrome P450 3A4 Inducers [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0245-1071 Qudexy 25 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, Inc.
  • 0245-1073 Qudexy 200 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, Inc.
  • 0245-1074 Qudexy 100 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, Inc.
  • 0245-1075 Qudexy 150 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, Inc.


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Notice: The MedsChat® NDC Database compiles 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.

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