FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
55111-272
11-digit product format
551110272
Labeler code
55111
Product ID
55111-272_45f79372-39c7-ae59-c119-51aece645ae0
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA075168
Marketing category
ANDA
Marketing start
1998-07-29
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
55111-272-01Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-01Naproxen Sodium100 in 1 BOTTLETABLET, COATED10013
55111-272-02Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-02Naproxen Sodium200 in 1 BOTTLETABLET, COATED20013
55111-272-05Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-05Naproxen Sodium500 in 1 BOTTLETABLET, COATED50013
55111-272-24Naproxen Sodium1 in 1 CARTONTABLET, COATED113
55111-272-24Naproxen Sodium24 in 1 BOTTLETABLET, COATED2413
55111-272-50Naproxen Sodium50 in 1 BOTTLETABLET, COATED5013
55111-272-50Naproxen Sodium1 in 1 CARTONTABLET, COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-272NAPROXEN SODIUM TABLET, COATED [DR.REDDY'S LABORATORIES LIMITED]12Current NDC, Legacy NDC, 10 package rows20221223_aca5d497-fbc6-464d-2dee-25c50e11bc78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNaca5d497-fbc6-464d-2dee-25c50e11bc7813
849574naproxen sodium 220 MG Oral TabletSCDaca5d497-fbc6-464d-2dee-25c50e11bc7813
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYaca5d497-fbc6-464d-2dee-25c50e11bc7813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-272-01551110272011 BOTTLE in 1 CARTON (55111-272-01) / 100 TABLET, COATED in 1 BOTTLE1 bottle1998-07-290000-00-00NoNoCurrent
55111-272-02551110272021 BOTTLE in 1 CARTON (55111-272-02) / 200 TABLET, COATED in 1 BOTTLE1 bottle1998-07-290000-00-00NoNoCurrent
55111-272-05551110272051 BOTTLE in 1 CARTON (55111-272-05) / 500 TABLET, COATED in 1 BOTTLE1 bottle1998-07-290000-00-00NoNoCurrent
55111-272-24551110272241 BOTTLE in 1 CARTON (55111-272-24) / 24 TABLET, COATED in 1 BOTTLE1 bottle1998-07-290000-00-00NoNoCurrent
55111-272-50551110272501 BOTTLE in 1 CARTON (55111-272-50) / 50 TABLET, COATED in 1 BOTTLE1 bottle1998-07-290000-00-00NoNoCurrent