NDC 0378-3502

Risperidone

Risperidone

Risperidone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Risperidone.

• Product ID: 0378-3502_bd55c402-c772-4adf-a9cc-129ab7f67fee
• NDC: 0378-3502
• Product Type: Human Prescription Drug
• Proprietary Name: Risperidone
• Generic Name: Risperidone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-09-17
• Marketing End Date: 2020-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076288
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: RISPERIDONE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0378-3502-05

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3502-05)

• Marketing Start Date: 2008-09-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3502-91 [00378350291]

Risperidone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA076288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-09-17
• Marketing End Date: 2020-05-31

NDC 0378-3502-01 [00378350201]

Risperidone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA076288
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-09-17
• Marketing End Date: 2014-09-15

NDC 0378-3502-05 [00378350205]

Risperidone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA076288
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-09-17
• Marketing End Date: 2020-05-31

Drug Details

Active Ingredients

Ingredient	Strength
RISPERIDONE	.25 mg/1

OpenFDA Data

• SPL SET ID: 1e4fe8ef-b215-be45-0793-c55af24db6bb
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • L6UH7ZF8HC
• RxNorm Concept Unique ID - RxCUI:
  • 314211
  • 312831
  • 312830
  • 312832
  • 312828
  • 312829

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