FDA.reportPublic FDA data

Naproxen

Product NDC
42708-043
11-digit product format
427080043
Labeler code
42708
Product ID
42708-043_46520e97-7fb6-0193-e063-6294a90a8784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Substance
NAPROXEN
Active strength
500 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-043-202021-03-12C16284748780-1ba0f9c33-3e7c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
42708-043-202021-01-29C16284748780-1ba0f9c33-3e7c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-043-20Naproxen20 in 1 BOTTLETABLET208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-043NAPROXEN TABLET [QPHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20241123_307aa67f-53b9-4c60-a328-091bbf6338d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN307aa67f-53b9-4c60-a328-091bbf6338d48
198014naproxen 500 MG Oral TabletSCD307aa67f-53b9-4c60-a328-091bbf6338d48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-043-204270800432020 TABLET in 1 BOTTLE (42708-043-20) 20 tablet2018-03-140000-00-00YesNoCurrent