Naproxen

Product NDC
31722-338
11-digit product format
317220338
Labeler code
31722
Product ID
31722-338_35bc8579-bca9-46a2-9303-5bcb760470d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA091432
Marketing category
ANDA
Marketing start
2012-01-23
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-338-052019-11-13C16284748780-197449f38-d247-f6ea-e053-dbdaa90aa703Naproxen Delayed-release Tablets USP, 375 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-338-01Naproxendelayed release100 in 1 BOTTLETABLET1001
31722-338-05Naproxendelayed release24 in 1 CASETABLET241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-338-01EA - Each31722-338a91204db-1d7e-4752-b574-996bc7c14bee12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-338NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1Legacy NDC, 2 package rows20120202_cb3897b7-d4f1-4081-bb3c-e5e270a84930.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSNcb3897b7-d4f1-4081-bb3c-e5e270a849301
311915naproxen 500 MG Delayed Release Oral TabletPSNcb3897b7-d4f1-4081-bb3c-e5e270a849301
603103naproxen 375 MG Delayed Release Oral TabletSCDcb3897b7-d4f1-4081-bb3c-e5e270a849301
311915naproxen 500 MG Delayed Release Oral TabletSCDcb3897b7-d4f1-4081-bb3c-e5e270a849301
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYcb3897b7-d4f1-4081-bb3c-e5e270a849301
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSYcb3897b7-d4f1-4081-bb3c-e5e270a849301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
31722-338-0131722033801100 in 1 BOTTLEHistorical
31722-338-053172203380524 in 1 CASEHistorical