EC-Naprosyn

Product NDC
69437-416
11-digit product format
694370416
Labeler code
69437
Product ID
69437-416_30e34aeb-4e90-4ba5-adc7-343806b104c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Canton Laboratories
Application
NDA020067
Marketing category
NDA
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69437-416-01EA - Each69437-416086706f9-88a6-4945-a00e-a9d3a39d687a12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69437-416NAPROSYN (NAPROXEN) TABLET EC-NAPROSYN (NAPROXEN) TABLET, DELAYED RELEASE ANAPROX DS (NAPROXEN SODIUM) TABLET [CANTON LABORATORIES]12Legacy NDC20250105_8bff5df5-d856-4237-b6a8-ae445b454844.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69437-416-0169437041601100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-416-01) 2016-06-010000-00-00NoNoCurrent