FDA.reportPublic FDA data

Naproxen

Product NDC
43353-216
11-digit product format
433530216
Labeler code
43353
Product ID
43353-216_68ef14c5-d88d-4c95-b6d4-65606f4c11fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091305
Marketing category
ANDA
Marketing start
2016-06-10
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
43353-216-60Naproxen90 in 1 BOTTLETABLET902
43353-216-70Naproxen120 in 1 BOTTLETABLET1202
43353-216-80Naproxen180 in 1 BOTTLETABLET1802
43353-216-94Naproxen360 in 1 BOTTLETABLET3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-216-60EA - Each43353-216e908ed4a-945e-48c3-8fa8-d784613146c612017-11-06
43353-216-70EA - Each43353-2167a111ef6-7698-4687-afee-da725bd7981012017-11-06
43353-216-80EA - Each43353-216d1e10135-731d-47e2-b6db-94d5dd27f95b12017-11-06
43353-216-94EA - Each43353-2162be47fef-a404-4618-aef7-ec80d773c2b412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-216NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20171026_e2347581-90da-429a-b17c-cffd0039fb86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198012naproxen 375 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198014naproxen 500 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198013naproxen 250 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862
198012naproxen 375 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862
198014naproxen 500 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-216-604335302166090 TABLET in 1 BOTTLE (43353-216-60) 90 tablet2016-08-180000-00-00NoNoCurrent
43353-216-7043353021670120 TABLET in 1 BOTTLE (43353-216-70) 120 tablet2016-08-180000-00-00NoNoCurrent
43353-216-8043353021680180 TABLET in 1 BOTTLE (43353-216-80) 180 tablet2016-08-220000-00-00NoNoCurrent
43353-216-9443353021694360 TABLET in 1 BOTTLE (43353-216-94) 360 tablet2016-08-220000-00-00NoNoCurrent