FDA.reportPublic FDA data

Naproxen

Product NDC
70518-4439
11-digit product format
705184439
Labeler code
70518
Product ID
70518-4439_4f0c17b4-ee4f-026c-e063-6394a90ac5c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074140
Marketing category
ANDA
Marketing start
2025-08-13
Substance
NAPROXEN
Active strength
500 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
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
70518-4439-0Naproxen12 in 1 BOTTLE, PLASTICTABLET125
70518-4439-1Naproxen20 in 1 BOTTLE, PLASTICTABLET205
70518-4439-2Naproxen30 in 1 BOTTLE, PLASTICTABLET305
70518-4439-3Naproxen90 in 1 BOTTLE, PLASTICTABLET905
70518-4439-4Naproxen30 in 1 BOTTLE, PLASTICTABLET305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN12202ef3-c65e-45a6-88ed-5d945d8fd41c5
198014naproxen 500 MG Oral TabletSCD12202ef3-c65e-45a6-88ed-5d945d8fd41c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4439-07051844390012 TABLET in 1 BOTTLE, PLASTIC (70518-4439-0) 12 tablet2025-08-13NoNoHistorical
70518-4439-17051844390120 TABLET in 1 BOTTLE, PLASTIC (70518-4439-1) 20 tablet2025-09-24NoNoHistorical
70518-4439-27051844390230 TABLET in 1 BOTTLE, PLASTIC (70518-4439-2) 30 tablet2026-01-06NoNoHistorical
70518-4439-37051844390390 TABLET in 1 BOTTLE, PLASTIC (70518-4439-3) 90 tablet2026-04-02NoNoHistorical
70518-4439-47051844390430 TABLET in 1 BOTTLE, PLASTIC (70518-4439-4) 30 tablet2026-04-09NoNoHistorical