Naproxen

Product NDC
50090-0483
11-digit product format
500900483
Labeler code
50090
Product ID
50090-0483_e24486ae-36f5-4052-8fc3-b0d579a20b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198014, 849431

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0483-0Naproxen20 in 1 BOTTLETABLET2035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0483-0EA - Each50090-048337cf26f0-5a1f-492a-b42c-fc37c6e121c112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0483NAPROXEN TABLET NAPROXEN SODIUM TABLET [A-S MEDICATION SOLUTIONS]33Current NDC, Legacy NDC, 1 package rows20241018_9d28422f-6f25-4f14-9272-e0907c971f33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
198014naproxen 500 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
198012naproxen 375 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
198014naproxen 500 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY9d28422f-6f25-4f14-9272-e0907c971f3335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0483-05009004830020 TABLET in 1 BOTTLE (50090-0483-0) 20 tablet2014-11-280000-00-00NoNoCurrent