NDC 27808-002

Risperidone

Risperidone

Risperidone is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc. The primary component is Risperidone.

Product ID27808-002_93d287c9-9ee8-48ff-b069-98505104e68e
NDC27808-002
Product TypeHuman Prescription Drug
Proprietary NameRisperidone
Generic NameRisperidone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-03-13
Marketing CategoryANDA / ANDA
Application NumberANDA079059
Labeler NameTris Pharma Inc
Substance NameRISPERIDONE
Active Ingredient Strength1 mg/mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 27808-002-01

30 mL in 1 BOTTLE, UNIT-DOSE (27808-002-01)
Marketing Start Date2015-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27808-002-01 [27808000201]

Risperidone SOLUTION
Marketing CategoryANDA
Application NumberANDA079059
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-13
Marketing End Date2016-11-29

Drug Details

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

NDCBrand NameGeneric Name
0054-0063RisperidoneRisperidone
0378-3502Risperidonerisperidone
0378-3505Risperidonerisperidone
0378-3511Risperidonerisperidone
0378-3512Risperidonerisperidone
0378-3513Risperidonerisperidone
0378-3514Risperidonerisperidone
0603-9424RisperidoneRisperidone
0615-7505Risperidonerisperidone
0615-7506Risperidonerisperidone
0615-7507Risperidonerisperidone
0615-8196RisperidoneRisperidone
0615-8197RisperidoneRisperidone
0615-8198RisperidoneRisperidone
0615-8265RisperidoneRisperidone
0615-8288RisperidoneRisperidone
0781-5310RisperidoneRisperidone
0781-5311RisperidoneRisperidone
0781-5312RisperidoneRisperidone
0781-5313RisperidoneRisperidone
68071-2138risperidonerisperidone
68071-3356RISPERIDONERISPERIDONE
68071-3369risperidonerisperidone
68071-4618RISPERIDONERISPERIDONE
68084-271RisperidoneRisperidone
68084-274RisperidoneRisperidone
68084-270RisperidoneRisperidone
68084-272RisperidoneRisperidone
68084-277RisperidoneRisperidone
68084-273RisperidoneRisperidone
68151-0317RisperidoneRisperidone
68382-112risperidonerisperidone
68382-114risperidonerisperidone
68382-113risperidonerisperidone
68382-156risperidonerisperidone
68382-116risperidonerisperidone
68382-154risperidonerisperidone
68382-117risperidonerisperidone
68382-155risperidonerisperidone
68382-115risperidonerisperidone
68788-7211RISPERIDONERISPERIDONE
70518-0364RISPERIDONERISPERIDONE
70518-0979risperidonerisperidone
70518-0978risperidonerisperidone
70518-1575RISPERIDONERISPERIDONE
70518-1613RISPERIDONERISPERIDONE
70518-1151risperidonerisperidone
70518-1502RISPERIDONERISPERIDONE
70518-1631RISPERIDONERISPERIDONE
70518-1574risperidonerisperidone

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.