FDA.reportPublic FDA data

Naproxen

Product NDC
70518-3822
11-digit product format
705183822
Labeler code
70518
Product ID
70518-3822_3f665aca-7ee1-dce4-e063-6394a90a3075
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2023-08-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

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
70518-3822-0Naproxen30 in 1 BLISTER PACKTABLET308
70518-3822-1Naproxen60 in 1 BOTTLE, PLASTICTABLET608
70518-3822-2Naproxen20 in 1 BOTTLE, PLASTICTABLET208
70518-3822-3Naproxen30 in 1 BOTTLE, PLASTICTABLET308
70518-3822-4Naproxen14 in 1 BOTTLE, PLASTICTABLET148
70518-3822-5Naproxen6 in 1 BLISTER PACKTABLET68
70518-3822-6Naproxen28 in 1 BOTTLE, PLASTICTABLET288
70518-3822-7Naproxen12 in 1 BOTTLE, PLASTICTABLET128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3822-1EA - Each70518-38220b97331a-046f-43a9-bf82-107d3c25e09c12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3822NAPROXEN TABLET [REMEDYREPACK INC.]7Current NDC, 8 package rows20241204_ccd95dfc-9236-4707-a715-6a12c91519ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNccd95dfc-9236-4707-a715-6a12c91519ff8
198014naproxen 500 MG Oral TabletSCDccd95dfc-9236-4707-a715-6a12c91519ff8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3822-07051838220030 TABLET in 1 BLISTER PACK (70518-3822-0) 30 tablet2023-08-06NoNoCurrent
70518-3822-17051838220160 TABLET in 1 BOTTLE, PLASTIC (70518-3822-1) 60 tablet2023-08-23NoNoCurrent
70518-3822-27051838220220 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2) 20 tablet2023-08-23NoNoCurrent
70518-3822-37051838220330 TABLET in 1 BOTTLE, PLASTIC (70518-3822-3) 30 tablet2023-08-24NoNoCurrent
70518-3822-47051838220414 TABLET in 1 BOTTLE, PLASTIC (70518-3822-4) 14 tablet2023-08-24NoNoCurrent
70518-3822-5705183822056 TABLET in 1 BLISTER PACK (70518-3822-5) 6 tablet2023-09-09NoNoCurrent
70518-3822-67051838220628 in 1 BOTTLE, PLASTICHistorical
70518-3822-77051838220712 TABLET in 1 BOTTLE, PLASTIC (70518-3822-7) 12 tablet2024-02-23NoNoCurrent