FDA.reportPublic FDA data

Naproxen

Product NDC
63187-461
11-digit product format
631870461
Labeler code
63187
Product ID
63187-461_9af6ee64-084d-4ad4-9cb4-e4812c4104c0
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
250 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
NAPROXEN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198013

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
63187-461-15Naproxen15 in 1 BOTTLETABLET154
63187-461-30Naproxen30 in 1 BOTTLETABLET304
63187-461-45Naproxen45 in 1 BOTTLETABLET454
63187-461-60Naproxen60 in 1 BOTTLETABLET604
63187-461-90Naproxen90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-461NAPROXEN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20220415_aa4d159c-9cbe-4d29-9532-33a312f1ae05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNaa4d159c-9cbe-4d29-9532-33a312f1ae054
198013naproxen 250 MG Oral TabletSCDaa4d159c-9cbe-4d29-9532-33a312f1ae054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-461-156318704611515 TABLET in 1 BOTTLE (63187-461-15) 15 tablet2019-01-010000-00-00NoNoCurrent
63187-461-306318704613030 TABLET in 1 BOTTLE (63187-461-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-461-456318704614545 TABLET in 1 BOTTLE (63187-461-45) 45 tablet2019-01-010000-00-00NoNoCurrent
63187-461-606318704616060 TABLET in 1 BOTTLE (63187-461-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-461-906318704619090 TABLET in 1 BOTTLE (63187-461-90) 90 tablet2019-01-010000-00-00NoNoCurrent