FDA.reportPublic FDA data

Naproxen

Product NDC
83209-190
11-digit product format
832090190
Labeler code
83209
Product ID
83209-190_205aec1c-4e2f-8e0f-e063-6294a90a4ff0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA078250
Marketing category
ANDA
Marketing start
2024-08-23
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
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
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
83209-190-14Naproxen14 in 1 BLISTER PACKTABLET141
83209-190-15Naproxen15 in 1 BLISTER PACKTABLET151
83209-190-18Naproxen18 in 1 BLISTER PACKTABLET181
83209-190-20Naproxen20 in 1 BLISTER PACKTABLET201
83209-190-28Naproxen28 in 1 BLISTER PACKTABLET281
83209-190-30Naproxen30 in 1 BLISTER PACKTABLET301
83209-190-60Naproxen60 in 1 BLISTER PACKTABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN205b1159-06e5-0d48-e063-6294a90acbd81
198014naproxen 500 MG Oral TabletSCD205b1159-06e5-0d48-e063-6294a90acbd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-190-148320901901414 TABLET in 1 BLISTER PACK (83209-190-14) 14 tablet2024-08-23NoNoHistorical
83209-190-158320901901515 TABLET in 1 BLISTER PACK (83209-190-15) 15 tablet2024-08-23NoNoHistorical
83209-190-188320901901818 TABLET in 1 BLISTER PACK (83209-190-18) 18 tablet2024-08-23NoNoHistorical
83209-190-208320901902020 TABLET in 1 BLISTER PACK (83209-190-20) 20 tablet2024-08-23NoNoHistorical
83209-190-288320901902828 TABLET in 1 BLISTER PACK (83209-190-28) 28 tablet2024-08-23NoNoHistorical
83209-190-308320901903030 TABLET in 1 BLISTER PACK (83209-190-30) 30 tablet2024-08-23NoNoHistorical
83209-190-608320901906060 TABLET in 1 BLISTER PACK (83209-190-60) 60 tablet2024-08-23NoNoHistorical