FDA.reportPublic FDA data

equaline naproxen sodium

Product NDC
41163-511
11-digit product format
411630511
Labeler code
41163
Product ID
41163-511_e75cd375-b00e-4087-9152-7f2a8ec7cf8f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA074661
Marketing category
ANDA
Marketing start
2014-09-24
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
equaline naproxen sodium
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
41163-511-62equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
41163-511-62equaline naproxen sodium24 in 1 BOTTLETABLET, FILM COATED247
41163-511-71equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
41163-511-71equaline naproxen sodium50 in 1 BOTTLETABLET, FILM COATED507
41163-511-75equaline naproxen sodium90 in 1 BOTTLETABLET, FILM COATED907
41163-511-75equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
41163-511-78equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED17
41163-511-78equaline naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-511EQUALINE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 8 package rows20230826_1022d075-9bdf-46df-81ac-c84cb2608195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN1022d075-9bdf-46df-81ac-c84cb26081957
849574naproxen sodium 220 MG Oral TabletSCD1022d075-9bdf-46df-81ac-c84cb26081957
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1022d075-9bdf-46df-81ac-c84cb26081957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-511-62411630511621 BOTTLE in 1 CARTON (41163-511-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-240000-00-00NoNoCurrent
41163-511-71411630511711 BOTTLE in 1 CARTON (41163-511-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-240000-00-00NoNoCurrent
41163-511-75411630511751 BOTTLE in 1 CARTON (41163-511-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-09-210000-00-00NoNoCurrent
41163-511-78411630511781 BOTTLE in 1 CARTON (41163-511-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-240000-00-00NoNoCurrent