Risperidone

Product NDC
0781-5314
11-digit product format
007815314
Labeler code
0781
Product ID
0781-5314_483b5267-344e-4ba9-b6d8-a8bff8f7108e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078116
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
4 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5314-06EA - Each0781-5314c5f8c4b4-39b1-4ce5-baa5-f330245e5dc412016-12-07
0781-5314-08EA - Each0781-5314621c5351-7bab-4573-8aed-24eb4b78c44d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5314-080078153140828 BLISTER PACK in 1 CARTON (0781-5314-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5314-06) 28 blister pack2009-12-220000-00-00NoNoCurrent