NAPROXEN

Product NDC
69543-426
11-digit product format
695430426
Labeler code
69543
Product ID
69543-426_2c77658c-b5b6-4d22-a218-1334a0d13c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA091432
Marketing category
ANDA
Marketing start
2019-11-15
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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
69543-426-10EA - Each69543-4267f61c82b-f86a-4227-901a-12ea002ca76b12019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69543-426-1069543042610100 TABLET, DELAYED RELEASE in 1 BOTTLE (69543-426-10) 2019-11-150000-00-00NoNoCurrent