PEXEVA

Product NDC
54766-203
11-digit product format
547660203
Labeler code
54766
Product ID
54766-203_e30fbd74-babc-9f31-e053-2995a90a73d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sebela Pharmaceuticals Inc.
Application
NDA021299
Marketing category
NDA
Marketing start
2017-06-02
Marketing end
0000-00-00
Substance
PAROXETINE MESYLATE
Active strength
30 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-203-01EA - Each54766-2032ca4f5e9-df2c-4975-81f6-ffa35e8812e312017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54766-203-015476602030130 TABLET, FILM COATED in 1 BOTTLE (54766-203-01) 2017-06-020000-00-00NoNoCurrent