Naproxen

Product NDC
63874-325
11-digit product format
638740325
Labeler code
63874
Product ID
63874-325_feb7a143-ac2f-48fd-a2d1-1475337efacf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Altura Pharmaceuticals, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2010-01-01
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63874-325-01Naproxen100 in 1 BOTTLE, PLASTICTABLET1001
63874-325-30Naproxen30 in 1 BOTTLE, PLASTICTABLET301
63874-325-60Naproxen60 in 1 BOTTLE, PLASTICTABLET601
63874-325-90Naproxen90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63874-325-01EA - Each63874-32543857621-51fe-464b-9e5e-24d2d224a85212012-07-24
63874-325-30EA - Each63874-3256359772a-4637-4174-9795-29c54a0ca3b912012-07-24
63874-325-60EA - Each63874-325d4d90e01-acc1-4c1f-abb6-5af330a8c72712012-07-24
63874-325-90EA - Each63874-32551d8adcb-a357-4847-9fa6-61952b9c1f8412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63874-325NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20100430_4bbe6e74-b13e-4609-b4cc-aa0b00d66df8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198012naproxen 375 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198014naproxen 500 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198013naproxen 250 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198012naproxen 375 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198014naproxen 500 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY4bbe6e74-b13e-4609-b4cc-aa0b00d66df81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63874-325-0163874032501100 in 1 BOTTLE, PLASTICHistorical
63874-325-306387403253030 in 1 BOTTLE, PLASTICHistorical
63874-325-606387403256060 in 1 BOTTLE, PLASTICHistorical
63874-325-906387403259090 in 1 BOTTLE, PLASTICHistorical