Naproxen Sodium PM

Product NDC
55910-854
11-digit product format
559100854
Labeler code
55910
Product ID
55910-854_a662cc95-9cef-4ee0-a4bd-c75b20392d78
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA209726
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
2025-09-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-854NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Legacy NDC20221203_a16d1925-c01e-4a00-ba01-e9d699b65e7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-854-20559100854201 BOTTLE, PLASTIC in 1 BOX (55910-854-20) > 20 TABLET in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent
55910-854-40559100854401 BOTTLE, PLASTIC in 1 BOX (55910-854-40) > 40 TABLET in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent