EC-NAPROXEN

Product NDC
69784-501
11-digit product format
697840501
Labeler code
69784
Product ID
69784-501_e7975860-648a-454a-b324-9d7824f92521
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
NDA020067
Marketing category
NDA
Marketing start
2018-10-15
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-501-01EA - Each69784-501cdcada2b-3917-403c-a70d-dc9537f18c4412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-501NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [WOODWARD PHARMA SERVICES LLC]5Legacy NDC20240415_0728935b-19fc-4a10-aeba-29c42ce7f472.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69784-501-0169784050101100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-501-01) 2018-10-150000-00-00NoNoCurrent