NDC 0781-5311

Risperidone

Risperidone

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

• Product ID: 0781-5311_0ca9e8a6-9431-469a-97e2-f57b7e3fe57e
• NDC: 0781-5311
• Product Type: Human Prescription Drug
• Proprietary Name: Risperidone
• Generic Name: Risperidone
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2009-12-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078116
• Labeler Name: Sandoz 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 0781-5311-08

28 BLISTER PACK in 1 CARTON (0781-5311-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5311-06)

• Marketing Start Date: 2009-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-5311-08 [00781531108]

Risperidone TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA078116
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-22

NDC 0781-5311-64 [00781531164]

Risperidone TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA078116
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-12-22
• Marketing End Date: 2016-05-06

NDC 0781-5311-06 [00781531106]

Risperidone TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA078116
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-17

Drug Details

Active Ingredients

Ingredient	Strength
RISPERIDONE	1 mg/1

OpenFDA Data

• SPL SET ID: e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
• Manufacturer:
  • Sandoz Inc
• UNII:
  • L6UH7ZF8HC
• RxNorm Concept Unique ID - RxCUI:
  • 401953
  • 616705
  • 403825
  • 616698
  • 401954
• UPC Code:
  • 0307815313081
  • 0307815312084
  • 0307815310080
  • 0307815311087
  • 0307815314088

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