NAPROXEN

Product NDC
67296-1609
11-digit product format
672961609
Labeler code
67296
Product ID
67296-1609_d61c347b-4221-e018-e053-2995a90a4f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1609-1NAPROXEN14 in 1 BOTTLETABLET1412
67296-1609-3NAPROXEN30 in 1 BOTTLETABLET3012
67296-1609-6NAPROXEN60 in 1 BOTTLETABLET6012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1609NAPROXEN TABLET [REDPHARM DRUG, INC.]12Legacy NDC, 3 package rows20240816_7b214238-de65-2f02-e053-2a91aa0a16db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN7b214238-de65-2f02-e053-2a91aa0a16db12
198014naproxen 500 MG Oral TabletSCD7b214238-de65-2f02-e053-2a91aa0a16db12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1609-16729616090114 TABLET in 1 BOTTLE (67296-1609-1) 14 tablet2018-01-010000-00-00NoNoCurrent
67296-1609-36729616090330 TABLET in 1 BOTTLE (67296-1609-3) 30 tablet2018-01-010000-00-00NoNoCurrent
67296-1609-66729616090660 TABLET in 1 BOTTLE (67296-1609-6) 60 tablet2018-01-010000-00-00NoNoCurrent