Naproxen Sodium

Product NDC
62207-729
11-digit product format
622070729
Labeler code
62207
Product ID
62207-729_f4026a0a-c9cd-3850-e053-2995a90a459c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Ltd
Application
ANDA091353
Marketing category
ANDA
Marketing start
2018-06-08
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMGranules India Ltd95ba1722-60ed-4a83-9f26-50c4de8cf1802023-02-06WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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
62207-729-24Naproxen Sodium24 in 1 BOTTLETABLET249
62207-729-42Naproxen Sodium50 in 1 BOTTLETABLET509
62207-729-43Naproxen Sodium100 in 1 BOTTLETABLET1009
62207-729-47Naproxen Sodium500 in 1 BOTTLETABLET5009
62207-729-49Naproxen Sodium1000 in 1 BOTTLETABLET10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-729NAPROXEN SODIUM TABLET NAPROXEN SODIUM TABLET, FILM COATED [GRANULES INDIA LTD]9Current NDC, Legacy NDC, 5 package rows20230207_95ba1722-60ed-4a83-9f26-50c4de8cf180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN95ba1722-60ed-4a83-9f26-50c4de8cf1809
849574naproxen sodium 220 MG Oral TabletSCD95ba1722-60ed-4a83-9f26-50c4de8cf1809
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY95ba1722-60ed-4a83-9f26-50c4de8cf1809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-729-246220707292424 TABLET in 1 BOTTLE (62207-729-24) 24 tablet2018-06-080000-00-00NoNoCurrent
62207-729-426220707294250 TABLET in 1 BOTTLE (62207-729-42) 50 tablet2018-06-080000-00-00NoNoCurrent
62207-729-4362207072943100 TABLET in 1 BOTTLE (62207-729-43) 100 tablet2018-06-080000-00-00NoNoCurrent
62207-729-4762207072947500 TABLET in 1 BOTTLE (62207-729-47) 500 tablet2018-06-080000-00-00NoNoCurrent
62207-729-49622070729491000 TABLET in 1 BOTTLE (62207-729-49) 1000 tablet2018-06-080000-00-00NoNoCurrent