FDA.reportPublic FDA data

naproxen

Product NDC
69097-853
11-digit product format
690970853
Labeler code
69097
Product ID
69097-853_598c64ad-f0c4-495e-b2c2-cde215d2572d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA091305
Marketing category
ANDA
Marketing start
2016-07-05
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
Rxcui198012, 198013, 198014

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
69097-853-07naproxen100 in 1 BOTTLETABLET1005
69097-853-12naproxen500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-853-07EA - Each69097-853584b37e7-dda5-42ac-8b23-eabf37ca936912016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-853NAPROXEN TABLET [CIPLA USA INC.]5Current NDC, Legacy NDC, 2 package rows20230119_a9549a47-3fa4-4a2b-95ac-b00e43aedae7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198012naproxen 375 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198014naproxen 500 MG Oral TabletPSNa7f0801c-96de-4d28-b221-627372f2bebd13
198013naproxen 250 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13
198012naproxen 375 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13
198014naproxen 500 MG Oral TabletSCDa7f0801c-96de-4d28-b221-627372f2bebd13
198013naproxen 250 MG Oral TabletPSNa9549a47-3fa4-4a2b-95ac-b00e43aedae75
198012naproxen 375 MG Oral TabletPSNa9549a47-3fa4-4a2b-95ac-b00e43aedae75
198014naproxen 500 MG Oral TabletPSNa9549a47-3fa4-4a2b-95ac-b00e43aedae75
198013naproxen 250 MG Oral TabletSCDa9549a47-3fa4-4a2b-95ac-b00e43aedae75
198012naproxen 375 MG Oral TabletSCDa9549a47-3fa4-4a2b-95ac-b00e43aedae75
198014naproxen 500 MG Oral TabletSCDa9549a47-3fa4-4a2b-95ac-b00e43aedae75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-853-0769097085307100 TABLET in 1 BOTTLE (69097-853-07) 100 tablet2016-07-050000-00-00NoNoCurrent
69097-853-1269097085312500 TABLET in 1 BOTTLE (69097-853-12) 500 tablet2016-07-050000-00-00NoNoCurrent