equaline naproxen sodium

Product NDC
41163-707
11-digit product format
411630707
Labeler code
41163
Product ID
41163-707_726f2b53-4a2f-42db-8e7c-75da538df3fd
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equaline naproxen sodium
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-707-71equaline naproxen sodium50 in 1 BOTTLETABLET, FILM COATED508
41163-707-71equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED18
41163-707-75equaline naproxen sodium90 in 1 BOTTLETABLET, FILM COATED908
41163-707-75equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED18
41163-707-78equaline naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1008
41163-707-78equaline naproxen sodium1 in 1 CARTONTABLET, FILM COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-707EQUALINE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 6 package rows20240906_89c02e55-fa08-4001-96fc-8a01e7e74d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN89c02e55-fa08-4001-96fc-8a01e7e74d5a8
849574naproxen sodium 220 MG Oral TabletSCD89c02e55-fa08-4001-96fc-8a01e7e74d5a8
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY89c02e55-fa08-4001-96fc-8a01e7e74d5a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-707-71411630707711 BOTTLE in 1 CARTON (41163-707-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-240000-00-00NoNoCurrent
41163-707-75411630707751 BOTTLE in 1 CARTON (41163-707-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-210000-00-00NoNoCurrent
41163-707-78411630707781 BOTTLE in 1 CARTON (41163-707-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-09-240000-00-00NoNoCurrent