FDA.reportPublic FDA data

Naproxen

Product NDC
51655-743
11-digit product format
516550743
Labeler code
51655
Product ID
51655-743_4ba9ffdd-00a3-39ed-e063-6394a90ab827
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-06-29
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-743-522023-04-18C16284748780-1f386c64a-0074-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
51655-743-522023-01-30C16284748780-1f386c64a-0074-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-743-20Naproxen20 in 1 BOTTLE, PLASTICTABLET205
51655-743-25Naproxen60 in 1 BOTTLE, PLASTICTABLET605
51655-743-26Naproxen90 in 1 BOTTLE, PLASTICTABLET905
51655-743-52Naproxen30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-743NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 4 package rows20230419_c986ba9a-6f48-8347-e053-2a95a90aa1c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNc986ba9a-6f48-8347-e053-2a95a90aa1c15
198014naproxen 500 MG Oral TabletSCDc986ba9a-6f48-8347-e053-2a95a90aa1c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-743-205165507432020 TABLET in 1 BOTTLE, PLASTIC (51655-743-20) 20 tablet2022-04-20NoNoCurrent
51655-743-255165507432560 TABLET in 1 BOTTLE, PLASTIC (51655-743-25) 60 tablet2022-02-18NoNoCurrent
51655-743-265165507432690 TABLET in 1 BOTTLE, PLASTIC (51655-743-26) 90 tablet2022-01-20NoNoCurrent
51655-743-525165507435230 TABLET in 1 BOTTLE, PLASTIC (51655-743-52) 30 tablet2021-06-290000-00-00NoNoCurrent