Naprosyn

Product NDC
69437-316
11-digit product format
694370316
Labeler code
69437
Product ID
69437-316_30e34aeb-4e90-4ba5-adc7-343806b104c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Canton Laboratories
Application
NDA017581
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
69437-316-01EA - Each69437-3165270eaa1-fe43-45f4-a513-4c0e8a6077ab12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69437-316NAPROSYN (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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69437-316-0169437031601100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01) 100 tablet2016-06-010000-00-00NoNoCurrent