FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
59726-174
11-digit product format
597260174
Labeler code
59726
Product ID
59726-174_2099e3fb-d761-4735-9935-c51413496741
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA208363
Marketing category
ANDA
Marketing start
2018-04-01
Marketing end
2026-12-31
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1112231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-174-202025-08-19C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-802025-08-19C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-202025-01-30C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-802025-01-30C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-202023-04-19C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-802023-04-19C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-202023-01-30C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts
59726-174-802023-01-30C16284748780-1f386c649-e186-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-174-20Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED17
59726-174-20Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED207
59726-174-80Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED17
59726-174-80Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-174NAPROXEN SODIUM CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 4 package rows20230420_fc65fe79-c93b-4247-b9af-e562792a3e64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSNfc65fe79-c93b-4247-b9af-e562792a3e647
1112231naproxen sodium 220 MG Oral CapsuleSCDfc65fe79-c93b-4247-b9af-e562792a3e647
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSYfc65fe79-c93b-4247-b9af-e562792a3e647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-174-20597260174201 BOTTLE, PLASTIC in 1 BOX (59726-174-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-012026-12-31NoNoCurrent
59726-174-80597260174801 BOTTLE, PLASTIC in 1 BOX (59726-174-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-012026-12-31NoNoCurrent