Naproxen

Product NDC
63187-535
11-digit product format
631870535
Labeler code
63187
Product ID
63187-535_bd0691c5-aaa9-472e-9b05-926d93defd0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Substance
NAPROXEN
Active strength
375 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
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012

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
63187-535-15Naproxen15 in 1 BOTTLETABLET153
63187-535-20Naproxen20 in 1 BOTTLETABLET203
63187-535-30Naproxen30 in 1 BOTTLETABLET303
63187-535-45Naproxen45 in 1 BOTTLETABLET453
63187-535-60Naproxen60 in 1 BOTTLETABLET603
63187-535-90Naproxen90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-535NAPROXEN TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20210114_3e4e5371-d796-47c7-95c1-d99e82a0b282.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN3e4e5371-d796-47c7-95c1-d99e82a0b2823
198012naproxen 375 MG Oral TabletSCD3e4e5371-d796-47c7-95c1-d99e82a0b2823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-535-156318705351515 TABLET in 1 BOTTLE (63187-535-15) 15 tablet2018-12-010000-00-00NoNoCurrent
63187-535-206318705352020 TABLET in 1 BOTTLE (63187-535-20) 20 tablet2018-12-010000-00-00NoNoCurrent
63187-535-306318705353030 TABLET in 1 BOTTLE (63187-535-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-535-456318705354545 TABLET in 1 BOTTLE (63187-535-45) 45 tablet2018-12-010000-00-00NoNoCurrent
63187-535-606318705356060 TABLET in 1 BOTTLE (63187-535-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-535-906318705359090 TABLET in 1 BOTTLE (63187-535-90) 90 tablet2018-12-010000-00-00NoNoCurrent