Naproxen Sodium

Product NDC
70518-2863
11-digit product format
705182863
Labeler code
70518
Product ID
70518-2863_dfe98d6e-f5d1-161b-e053-2995a90a1257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212199
Marketing category
ANDA
Marketing start
2020-08-27
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2863-02022-02-07C16284748780-1d6a99b39-7a48-a426-e053-dadaa90af4c23882db3d-acb9-4eb8-896f-55697a2a955c
70518-2863-02022-01-28C16284748780-1d6a99b39-7a48-a426-e053-dadaa90af4c23882db3d-acb9-4eb8-896f-55697a2a955c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2863NAPROXEN SODIUM TABLET [REMEDYREPACK INC.]9Legacy NDC20240921_3882db3d-acb9-4eb8-896f-55697a2a955c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2863-07051828630030 TABLET in 1 BOTTLE, PLASTIC (70518-2863-0) 30 tablet2020-08-270000-00-00NoNoCurrent
70518-2863-17051828630130 TABLET in 1 BOTTLE, PLASTIC (70518-2863-1) 30 tablet2022-05-240000-00-00NoNoCurrent