FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
21130-948
11-digit product format
211300948
Labeler code
21130
Product ID
21130-948_23615188-2795-b75b-e063-6394a90a9728
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Albertsons Companies
Application
NDA021920
Marketing category
NDA
Marketing start
2023-09-26
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
21130-948-11Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED13
21130-948-11Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED203
21130-948-15Naproxen Sodium40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED403
21130-948-15Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED13
21130-948-16Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED13
21130-948-16Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED503
21130-948-78Naproxen Sodium80 in 1 BOTTLECAPSULE, LIQUID FILLED803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-948NAPROXEN SODIUM CAPSULE, LIQUID FILLED [ALBERTSONS COMPANIES]3Current NDC, 7 package rows20241003_f9df7495-9da7-8838-e053-6294a90a6fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSNf9df7495-9da7-8838-e053-6294a90a6fda3
1112231naproxen sodium 220 MG Oral CapsuleSCDf9df7495-9da7-8838-e053-6294a90a6fda3
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSYf9df7495-9da7-8838-e053-6294a90a6fda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21130-948-11211300948111 BOTTLE, PLASTIC in 1 CARTON (21130-948-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-09-26NoNoHistorical
21130-948-15211300948151 BOTTLE, PLASTIC in 1 CARTON (21130-948-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-09-26NoNoHistorical
21130-948-16211300948161 BOTTLE, PLASTIC in 1 CARTON (21130-948-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2024-10-01NoNoHistorical
21130-948-782113009487880 CAPSULE, LIQUID FILLED in 1 BOTTLE (21130-948-78) 2023-09-26NoNoHistorical