Naproxen

Product NDC
45865-867
11-digit product format
458650867
Labeler code
45865
Product ID
45865-867_7dc9f5d6-9bdf-018b-e053-2a91aa0a3138
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA075227
Marketing category
ANDA
Marketing start
1998-07-29
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-867-30Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE301
45865-867-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE601
45865-867-90Naproxen90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-867NAPROXEN TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 3 package rows20181225_7dc9f5d6-9bde-018b-e053-2a91aa0a3138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSN7dc9f5d6-9bde-018b-e053-2a91aa0a31381
311915naproxen 500 MG Delayed Release Oral TabletSCD7dc9f5d6-9bde-018b-e053-2a91aa0a31381
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY7dc9f5d6-9bde-018b-e053-2a91aa0a31381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-867-304586508673030 in 1 BOTTLEHistorical
45865-867-604586508676060 in 1 BOTTLEHistorical
45865-867-904586508679090 in 1 BOTTLEHistorical