BRISDELLE

Product NDC
54766-907
11-digit product format
547660907
Labeler code
54766
Product ID
54766-907_e190f18a-ef9d-7e9e-e053-2995a90af934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Sebela Pharmaceuticals Inc.
Application
NDA204516
Marketing category
NDA
Marketing start
2017-05-23
Marketing end
2023-01-31
Substance
PAROXETINE MESYLATE
Active strength
8 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-907-53EA - Each54766-907959fd2f8-b0a2-4044-bbfe-713898b0b9c812017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-907-535476609075330 CAPSULE in 1 BLISTER PACK (54766-907-53) 30 capsule2017-05-230000-00-00NoNoCurrent