FDA.reportPublic FDA data

Naproxen

Product NDC
21130-062
11-digit product format
211300062
Labeler code
21130
Product ID
21130-062_4650a28b-d299-a5e5-e063-6294a90ad9f7
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Safeway, Inc
Application
ANDA091353
Marketing category
ANDA
Marketing start
2023-08-30
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
21130-062-05Naproxen50 in 1 BOTTLETABLET505
21130-062-09Naproxen90 in 1 BOTTLETABLET905
21130-062-20Naproxen200 in 1 BOTTLETABLET2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-062NAPROXEN TABLET [SAFEWAY, INC]4Current NDC, 3 package rows20241212_f2a273f8-d623-dc2f-e053-2995a90a0c02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNf2a273f8-d623-dc2f-e053-2995a90a0c025
849574naproxen sodium 220 MG Oral TabletSCDf2a273f8-d623-dc2f-e053-2995a90a0c025
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf2a273f8-d623-dc2f-e053-2995a90a0c025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-062-052113000620550 TABLET in 1 BOTTLE (21130-062-05) 50 tablet2023-08-30NoNoHistorical
21130-062-092113000620990 TABLET in 1 BOTTLE (21130-062-09) 90 tablet2023-08-30NoNoHistorical
21130-062-2021130006220200 TABLET in 1 BOTTLE (21130-062-20) 200 tablet2023-09-30NoNoHistorical