NDC 50458-305

RISPERDAL

Risperidone

RISPERDAL is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Risperidone.

• Product ID: 50458-305_22c3bebb-b2f7-4e8e-8877-d5c664e3f27f
• NDC: 50458-305
• Product Type: Human Prescription Drug
• Proprietary Name: RISPERDAL
• Generic Name: Risperidone
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1996-06-10
• Marketing Category: NDA / NDA
• Application Number: NDA020588
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: RISPERIDONE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50458-305-03

30 mL in 1 BOTTLE (50458-305-03)

• Marketing Start Date: 1996-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-305-03 [50458030503]

RISPERDAL SOLUTION

• Marketing Category: NDA
• Application Number: NDA020588
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1996-06-10

Drug Details

Active Ingredients

Ingredient	Strength
RISPERIDONE	1 mg/mL

OpenFDA Data

• SPL SET ID: 7e117c7e-02fc-4343-92a1-230061dfc5e0
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • L6UH7ZF8HC
• RxNorm Concept Unique ID - RxCUI:
  • 630974
  • 630890
  • 211489
  • 806299
  • 314211
  • 199387
  • 312831
  • 312830
  • 312832
  • 616698
  • 616705
  • 262222
  • 806297
  • 403825
  • 806298
  • 262077
  • 401953
  • 401954
  • 104784
  • 104781
  • 104782
  • 104783
  • 312828
  • 312829

Pharmacological Class

• Atypical Antipsychotic [EPC]

Medicade Reported Pricing

50458030503 RISPERDAL 1 MG/ML SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "RISPERDAL" or generic name "Risperidone"

NDC	Brand Name	Generic Name
70518-0159	RISPERDAL	RISPERDAL
70518-1763	RISPERDAL	RISPERDAL
21695-115	RISPERDAL	RISPERDAL
21695-113	RISPERDAL	RISPERDAL
50458-300	RISPERDAL	RISPERDAL
50458-320	RISPERDAL	RISPERDAL
50458-330	RISPERDAL	RISPERDAL
50458-350	RISPERDAL	RISPERDAL
50458-301	RISPERDAL	RISPERDAL
50458-302	RISPERDAL	RISPERDAL
50458-305	RISPERDAL	RISPERDAL
55289-465	RISPERDAL	RISPERDAL
55289-463	RISPERDAL	RISPERDAL
55289-491	RISPERDAL	RISPERDAL
55289-519	RISPERDAL	RISPERDAL
70518-2160	RISPERDAL	RISPERDAL
70518-2161	RISPERDAL	RISPERDAL
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