FDA.reportPublic FDA data

Naproxen

Product NDC
50090-6666
11-digit product format
500906666
Labeler code
50090
Product ID
50090-6666_e4ad6bc9-90ba-4e65-b323-14ecebff9912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200429
Marketing category
ANDA
Marketing start
2011-11-08
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
50090-6666-0Naproxen15 in 1 BOTTLETABLET151
50090-6666-1Naproxen20 in 1 BOTTLETABLET201
50090-6666-2Naproxen30 in 1 BOTTLETABLET301
50090-6666-4Naproxen14 in 1 BOTTLETABLET141
50090-6666-5Naproxen40 in 1 BOTTLETABLET401
50090-6666-6Naproxen100 in 1 BOTTLETABLET1001
50090-6666-7Naproxen60 in 1 BOTTLETABLET601
50090-6666-9Naproxen6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6666-0EA - Each50090-666650815f15-719c-4dee-b1c3-1d4ece9dc36012023-10-16
50090-6666-1EA - Each50090-66663f236794-8bbd-4aec-843f-4faff13c38cd12023-10-16
50090-6666-2EA - Each50090-666662404c1a-e5c6-4818-b8d3-3498ac041c8d12023-10-16
50090-6666-4EA - Each50090-666610d347c7-8240-474e-9397-e509bb1ad9c912023-10-16
50090-6666-5EA - Each50090-6666bc97099e-d9dd-4cef-85cd-0d14c2cd899b12023-10-16
50090-6666-6EA - Each50090-6666bc457ace-e6c4-4467-ba27-df0e570fac4212023-10-16
50090-6666-7EA - Each50090-6666cb85a468-80da-4c11-b1d8-8511a64614c912023-10-16
50090-6666-9EA - Each50090-666600d89812-aa12-47b9-a00d-f7b031ad8f4512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6666NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 8 package rows20230907_d801ba16-e2ec-4bb2-8cff-32388634b35a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNd801ba16-e2ec-4bb2-8cff-32388634b35a1
198014naproxen 500 MG Oral TabletSCDd801ba16-e2ec-4bb2-8cff-32388634b35a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6666-05009066660015 TABLET in 1 BOTTLE (50090-6666-0) 15 tablet2023-08-31NoNoCurrent
50090-6666-15009066660120 TABLET in 1 BOTTLE (50090-6666-1) 20 tablet2023-08-31NoNoCurrent
50090-6666-25009066660230 TABLET in 1 BOTTLE (50090-6666-2) 30 tablet2023-08-31NoNoCurrent
50090-6666-45009066660414 TABLET in 1 BOTTLE (50090-6666-4) 14 tablet2023-08-31NoNoCurrent
50090-6666-55009066660540 TABLET in 1 BOTTLE (50090-6666-5) 40 tablet2023-08-31NoNoCurrent
50090-6666-650090666606100 TABLET in 1 BOTTLE (50090-6666-6) 100 tablet2023-08-31NoNoCurrent
50090-6666-75009066660760 TABLET in 1 BOTTLE (50090-6666-7) 60 tablet2023-08-31NoNoCurrent
50090-6666-9500906666096 TABLET in 1 BOTTLE (50090-6666-9) 6 tablet2023-08-31NoNoCurrent