FDA.reportPublic FDA data

NAPROXEN

Product NDC
72189-136
11-digit product format
721890136
Labeler code
72189
Product ID
72189-136_2be91642-ea9b-b147-e063-6394a90a2d96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091416
Marketing category
ANDA
Marketing start
2020-10-15
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
72189-136-14NAPROXEN14 in 1 BOTTLETABLET147
72189-136-20NAPROXEN20 in 1 BOTTLETABLET207
72189-136-30NAPROXEN30 in 1 BOTTLETABLET307
72189-136-60NAPROXEN60 in 1 BOTTLETABLET607
72189-136-71NAPROXEN100 in 1 BOTTLETABLET1007
72189-136-90NAPROXEN90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-136-14EA - Each72189-1364a8e6b2d-2490-4916-a743-a1e96b91e2fd12022-05-04
72189-136-20EA - Each72189-1369f0efbb7-f405-4f30-a3ae-378b776be5a412022-11-07
72189-136-30EA - Each72189-136faa4cc46-6385-4d72-9005-b4dc5ae5beb612021-02-05
72189-136-71EA - Each72189-136fbaceb49-c494-4d45-84f9-c23ef1dd079112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-136NAPROXEN TABLET [DIRECT RX]7Current NDC, Legacy NDC, 6 package rows20250119_b1b78c49-82e9-2402-e053-2a95a90ae35f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNb1b78c49-82e9-2402-e053-2a95a90ae35f7
198014naproxen 500 MG Oral TabletSCDb1b78c49-82e9-2402-e053-2a95a90ae35f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-136-147218901361414 TABLET in 1 BOTTLE (72189-136-14) 14 tablet2020-10-150000-00-00NoNoCurrent
72189-136-207218901362020 TABLET in 1 BOTTLE (72189-136-20) 20 tablet2020-10-150000-00-00NoNoCurrent
72189-136-307218901363030 TABLET in 1 BOTTLE (72189-136-30) 30 tablet2020-10-150000-00-00NoNoCurrent
72189-136-607218901366060 TABLET in 1 BOTTLE (72189-136-60) 60 tablet2020-10-150000-00-00NoNoCurrent
72189-136-7172189013671100 TABLET in 1 BOTTLE (72189-136-71) 100 tablet2020-10-150000-00-00NoNoCurrent
72189-136-907218901369090 TABLET in 1 BOTTLE (72189-136-90) 90 tablet2020-10-150000-00-00NoNoCurrent