NDC 50458-601

Risperidone M-TAB

Risperidone

Risperidone M-TAB is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceutical, Inc.. The primary component is Risperidone.

• Product ID: 50458-601_3e524f1e-7ea8-11e8-83da-f59c9d46d017
• NDC: 50458-601
• Product Type: Human Prescription Drug
• Proprietary Name: Risperidone M-TAB
• Generic Name: Risperidone
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2003-04-02
• Marketing Category: NDA / NDA
• Application Number: NDA021444
• Labeler Name: Janssen Pharmaceutical, Inc.
• Substance Name: RISPERIDONE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-601-28

7 BLISTER PACK in 1 BOX (50458-601-28) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2003-04-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-601-30 [50458060130]

Risperidone M-TAB TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021444
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-02
• Marketing End Date: 2018-01-31

NDC 50458-601-28 [50458060128]

Risperidone M-TAB TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021444
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-04-02
• Marketing End Date: 2018-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RISPERIDONE	.5 mg/1

OpenFDA Data

• SPL SET ID: 701e1cd8-2868-4d29-85a9-a2212c88165f
• Manufacturer:
  • Janssen Pharmaceutical, Inc.
• UNII:
  • L6UH7ZF8HC
• RxNorm Concept Unique ID - RxCUI:
  • 401953
  • 616698
  • 401954
  • 616705
  • 314211
  • 199387
  • 312831
  • 312830
  • 312832
  • 403825
  • 312828
  • 312829

Pharmacological Class

• Atypical Antipsychotic [EPC]

Medicade Reported Pricing

50458060128 RISPERIDONE 0.5 MG ODT

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Risperidone M-TAB" or generic name "Risperidone"

NDC	Brand Name	Generic Name
50458-603	Risperidone M-TAB	Risperidone M-TAB
50458-601	Risperidone M-TAB	Risperidone M-TAB
50458-602	Risperidone M-TAB	Risperidone M-TAB
0054-0063	Risperidone	Risperidone
0378-3502	Risperidone	risperidone
0378-3505	Risperidone	risperidone
0378-3511	Risperidone	risperidone
0378-3512	Risperidone	risperidone
0378-3513	Risperidone	risperidone
0378-3514	Risperidone	risperidone
0603-9424	Risperidone	Risperidone
0615-7505	Risperidone	risperidone
0615-7506	Risperidone	risperidone
0615-7507	Risperidone	risperidone
0615-8196	Risperidone	Risperidone
0615-8197	Risperidone	Risperidone
0615-8198	Risperidone	Risperidone
0615-8265	Risperidone	Risperidone
0615-8288	Risperidone	Risperidone
0781-5310	Risperidone	Risperidone
0781-5311	Risperidone	Risperidone
0781-5312	Risperidone	Risperidone
0781-5313	Risperidone	Risperidone