NAPROXEN

Product NDC
68071-4006
11-digit product format
680714006
Labeler code
68071
Product ID
68071-4006_1d7a3c9a-73d5-5360-e063-6394a90aa3e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4006-12024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4006-1NAPROXEN10 in 1 BOTTLETABLET105
68071-4006-2NAPROXEN20 in 1 BOTTLETABLET205
68071-4006-3NAPROXEN30 in 1 BOTTLETABLET305
68071-4006-4NAPROXEN40 in 1 BOTTLETABLET405
68071-4006-5NAPROXEN15 in 1 BOTTLETABLET155
68071-4006-6NAPROXEN60 in 1 BOTTLETABLET605
68071-4006-7NAPROXEN14 in 1 BOTTLETABLET145
68071-4006-9NAPROXEN90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-4006-3EA - Each68071-40061ad25a3c-fb8a-4643-81d1-eaf0f866a40512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4006NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 8 package rows20240719_5487dee2-5c37-4348-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN5487dee2-5c37-4348-e054-00144ff8d46c5
198014naproxen 500 MG Oral TabletSCD5487dee2-5c37-4348-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4006-16807140060110 TABLET in 1 BOTTLE (68071-4006-1) 10 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-26807140060220 TABLET in 1 BOTTLE (68071-4006-2) 20 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-36807140060330 TABLET in 1 BOTTLE (68071-4006-3) 30 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-46807140060440 TABLET in 1 BOTTLE (68071-4006-4) 40 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-56807140060515 TABLET in 1 BOTTLE (68071-4006-5) 15 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-66807140060660 TABLET in 1 BOTTLE (68071-4006-6) 60 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-76807140060714 TABLET in 1 BOTTLE (68071-4006-7) 14 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-96807140060990 TABLET in 1 BOTTLE (68071-4006-9) 90 tablet2017-07-170000-00-00NoNoCurrent