FDA.reportPublic FDA data

Naproxen

Product NDC
72789-321
11-digit product format
727890321
Labeler code
72789
Product ID
72789-321_47a9956b-6ea0-c241-e063-6394a90ab439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-321-04Naproxen4 in 1 BOTTLE, PLASTICTABLET416
72789-321-15Naproxen15 in 1 BOTTLE, PLASTICTABLET1516
72789-321-20Naproxen20 in 1 BOTTLE, PLASTICTABLET2016
72789-321-30Naproxen30 in 1 BOTTLE, PLASTICTABLET3016
72789-321-60Naproxen60 in 1 BOTTLE, PLASTICTABLET6016
72789-321-90Naproxen90 in 1 BOTTLE, PLASTICTABLET9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-321NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, 6 package rows20240220_fa2fe6fd-c476-dd29-e053-6294a90a9e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNfa2fe6fd-c476-dd29-e053-6294a90a9e9e16
198014naproxen 500 MG Oral TabletSCDfa2fe6fd-c476-dd29-e053-6294a90a9e9e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-321-04727890321044 TABLET in 1 BOTTLE, PLASTIC (72789-321-04) 4 tablet2023-11-15NoNoCurrent
72789-321-157278903211515 TABLET in 1 BOTTLE, PLASTIC (72789-321-15) 15 tablet2023-06-09NoNoCurrent
72789-321-207278903212020 TABLET in 1 BOTTLE, PLASTIC (72789-321-20) 20 tablet2023-08-01NoNoCurrent
72789-321-307278903213030 TABLET in 1 BOTTLE, PLASTIC (72789-321-30) 30 tablet2023-04-25NoNoCurrent
72789-321-607278903216060 TABLET in 1 BOTTLE, PLASTIC (72789-321-60) 60 tablet2023-06-12NoNoCurrent
72789-321-907278903219090 TABLET in 1 BOTTLE, PLASTIC (72789-321-90) 90 tablet2023-09-29NoNoCurrent