FDA.reportPublic FDA data

up and up naproxen sodium

Product NDC
11673-909
11-digit product format
116730909
Labeler code
11673
Product ID
11673-909_90510c27-046d-456c-a8e1-68d25dd33c09
Type
HUMAN OTC DRUG
Nonproprietary name
naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA074661
Marketing category
ANDA
Marketing start
2020-02-14
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
up and up 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
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
11673-909-75up and up naproxen sodium90 in 1 BOTTLETABLET, FILM COATED906
11673-909-78up and up naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-909UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5Current NDC, Legacy NDC, 2 package rows20240502_b0e98603-94e9-474a-88a0-22042f461271.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNb0e98603-94e9-474a-88a0-22042f4612716
849574naproxen sodium 220 MG Oral TabletSCDb0e98603-94e9-474a-88a0-22042f4612716
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYb0e98603-94e9-474a-88a0-22042f4612716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11673-909-751167309097590 TABLET, FILM COATED in 1 BOTTLE (11673-909-75) 2022-02-100000-00-00NoNoCurrent
11673-909-7811673090978100 TABLET, FILM COATED in 1 BOTTLE (11673-909-78) 2020-02-140000-00-00NoNoCurrent