Naproxen Sodium

Product NDC
55289-367
11-digit product format
552890367
Labeler code
55289
Product ID
55289-367_dee8dec8-0c62-83bc-e053-2995a90ab743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-367NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]27Legacy NDC20250322_58caec51-74aa-44b8-9638-f7cca096a54a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-367-06552890367066 TABLET in 1 BOTTLE, PLASTIC (55289-367-06) 6 tablet2010-09-220000-00-00NoNoCurrent
55289-367-105528903671010 TABLET in 1 BOTTLE, PLASTIC (55289-367-10) 10 tablet2010-09-220000-00-00NoNoCurrent
55289-367-145528903671414 TABLET in 1 BOTTLE, PLASTIC (55289-367-14) 14 tablet2010-09-220000-00-00NoNoCurrent
55289-367-155528903671515 TABLET in 1 BOTTLE, PLASTIC (55289-367-15) 15 tablet2021-05-200000-00-00NoNoCurrent
55289-367-205528903672020 TABLET in 1 BOTTLE, PLASTIC (55289-367-20) 20 tablet2010-09-220000-00-00NoNoCurrent
55289-367-285528903672828 TABLET in 1 BOTTLE, PLASTIC (55289-367-28) 28 tablet2010-09-220000-00-00NoNoCurrent
55289-367-305528903673030 TABLET in 1 BOTTLE, PLASTIC (55289-367-30) 30 tablet2010-09-220000-00-00NoNoCurrent
55289-367-425528903674242 TABLET in 1 BOTTLE, PLASTIC (55289-367-42) 42 tablet2010-09-220000-00-00NoNoCurrent
55289-367-605528903676060 TABLET in 1 BOTTLE, PLASTIC (55289-367-60) 60 tablet2010-09-220000-00-00NoNoCurrent