FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
72036-145
11-digit product format
720360145
Labeler code
72036
Product ID
72036-145_35a6092f-696f-a6bc-e063-6394a90a79c7
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Harris Teeter
Application
ANDA079096
Marketing category
ANDA
Marketing start
2011-12-01
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
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
72036-145-01Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, COATED244
72036-145-01Naproxen Sodium1 in 1 CARTONTABLET, COATED14
72036-145-02Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED504
72036-145-02Naproxen Sodium1 in 1 CARTONTABLET, COATED14
72036-145-03Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, COATED1004
72036-145-03Naproxen Sodium1 in 1 CARTONTABLET, COATED14
72036-145-08Naproxen Sodium200 in 1 BOTTLE, PLASTICTABLET, COATED2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-145NAPROXEN SODIUM TABLET, COATED [HARRIS TEETER]4Current NDC, Legacy NDC, 7 package rows20250523_38543976-ccbe-4af9-b01d-ae102452d418.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN38543976-ccbe-4af9-b01d-ae102452d4184
849574naproxen sodium 220 MG Oral TabletSCD38543976-ccbe-4af9-b01d-ae102452d4184
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY38543976-ccbe-4af9-b01d-ae102452d4184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72036-145-01720360145011 BOTTLE, PLASTIC in 1 CARTON (72036-145-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2012-07-170000-00-00NoNoCurrent
72036-145-02720360145021 BOTTLE, PLASTIC in 1 CARTON (72036-145-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-145-03720360145031 BOTTLE, PLASTIC in 1 CARTON (72036-145-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-145-0872036014508200 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-145-08) 2014-10-280000-00-00NoNoCurrent