50458-335 : Risperdal 3 mg Disintegrating Tablet


NDC: 50458-335
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Risperdal M-tab
Dosage Form: Oral Tablet, Orally Disintegrating
Application #: NDA021444
Rev. Date: 


Appearance:


Markings: R3
Shapes:  Round
Colors:  Orange
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:

  • 50458-335-28: 7 BLISTER PACK IN 1 BOX (50458‑335‑28) > 4 TABLET, ORALLY DISINTEGRATING IN 1 BLISTER PACK

Active Ingredients:

  • Risperidone

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Gelatin
  • Mannitol
  • Glycine
  • Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)
  • Sodium Hydroxide
  • Aspartame
  • Ferric Oxide Red
  • Peppermint Oil
  • Xanthan Gum

Pharmaceutical Classes:

  • Atypical Antipsychotic [EPC]

Related Products:

Based on records with the same trade name.
  • 50458-315 Risperdal 1 mg Disintegrating Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-325 Risperdal 2 mg Disintegrating Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-355 Risperdal 4 mg Disintegrating Tablet by Janssen Pharmaceuticals, Inc.
  • 50458-395 Risperdal 0.5 mg Disintegrating Tablet by Janssen Pharmaceuticals, Inc.

NDC QR Code

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NDC 50458-335 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.