FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
63941-681
11-digit product format
639410681
Labeler code
63941
Product ID
63941-681_06d2daf1-3067-95e9-e063-6294a90aa789
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
NDA021920
Marketing category
NDA
Marketing start
2023-10-03
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-681-16Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED502
63941-681-16Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-681NAPROXEN SODIUM CAPSULE, LIQUID FILLED [VALU MERCHANDISERS COMPANY]2Current NDC, 2 package rows20231004_fed305f1-e32d-e1ff-e053-6294a90a273d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSNfed305f1-e32d-e1ff-e053-6294a90a273d2
1112231naproxen sodium 220 MG Oral CapsuleSCDfed305f1-e32d-e1ff-e053-6294a90a273d2
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSYfed305f1-e32d-e1ff-e053-6294a90a273d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63941-681-16639410681161 BOTTLE, PLASTIC in 1 CARTON (63941-681-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-10-03NoNoCurrent