NDC 55648-557

RISPERIDONE

Risperidone

RISPERIDONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Risperidone.

• Product ID: 55648-557_aaa62d0c-37d5-40a9-8940-2f2b7397197f
• NDC: 55648-557
• Product Type: Human Prescription Drug
• Proprietary Name: RISPERIDONE
• Generic Name: Risperidone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-10-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078871
• Labeler Name: WOCKHARDT LIMITED
• Substance Name: RISPERIDONE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 55648-557-04

60 TABLET, FILM COATED in 1 BOTTLE (55648-557-04)

• Marketing Start Date: 2008-10-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55648-557-04 [55648055704]

RISPERIDONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078871
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-10-09
• Inactivation Date: 2020-01-31

NDC 55648-557-02 [55648055702]

RISPERIDONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078871
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-10-09
• Inactivation Date: 2020-01-31

NDC 55648-557-01 [55648055701]

RISPERIDONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078871
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-10-09
• Inactivation Date: 2020-01-31

NDC 55648-557-03 [55648055703]

RISPERIDONE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078871
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-10-09
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RISPERIDONE	2 mg/1

OpenFDA Data

• SPL SET ID: e92a97ef-0fe3-40b1-a938-373293a75255
• Manufacturer:
  • WOCKHARDT LIMITED
• UNII:
  • L6UH7ZF8HC
• RxNorm Concept Unique ID - RxCUI:
  • 314211
  • 312831
  • 312830
  • 312832
  • 312828
  • 312829
• UPC Code:
  • 0364679572023
  • 0364679553046

Pharmacological Class

• Atypical Antipsychotic [EPC]

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

NDC	Brand Name	Generic Name
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
68071-2138	risperidone	risperidone
68071-3356	RISPERIDONE	RISPERIDONE
68071-3369	risperidone	risperidone
68071-4618	RISPERIDONE	RISPERIDONE
68084-271	Risperidone	Risperidone
68084-274	Risperidone	Risperidone
68084-270	Risperidone	Risperidone
68084-272	Risperidone	Risperidone
68084-277	Risperidone	Risperidone
68084-273	Risperidone	Risperidone
68151-0317	Risperidone	Risperidone
68382-112	risperidone	risperidone
68382-114	risperidone	risperidone
68382-113	risperidone	risperidone
68382-156	risperidone	risperidone
68382-116	risperidone	risperidone
68382-154	risperidone	risperidone
68382-117	risperidone	risperidone
68382-155	risperidone	risperidone
68382-115	risperidone	risperidone
68788-7211	RISPERIDONE	RISPERIDONE
70518-0364	RISPERIDONE	RISPERIDONE
70518-0979	risperidone	risperidone
70518-0978	risperidone	risperidone
70518-1575	RISPERIDONE	RISPERIDONE
70518-1613	RISPERIDONE	RISPERIDONE
70518-1151	risperidone	risperidone
70518-1502	RISPERIDONE	RISPERIDONE
70518-1631	RISPERIDONE	RISPERIDONE
70518-1574	risperidone	risperidone