FDA.reportPublic FDA data

Naproxen

Product NDC
71335-0345
11-digit product format
713350345
Labeler code
71335
Product ID
71335-0345_54192467-cd41-453a-9f0b-8cfa5c7b805b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
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
71335-0345-0Naproxen28 in 1 BOTTLETABLET2815
71335-0345-1Naproxen30 in 1 BOTTLETABLET3015
71335-0345-2Naproxen60 in 1 BOTTLETABLET6015
71335-0345-3Naproxen10 in 1 BOTTLETABLET1015
71335-0345-4Naproxen90 in 1 BOTTLETABLET9015
71335-0345-5Naproxen20 in 1 BOTTLETABLET2015
71335-0345-6Naproxen120 in 1 BOTTLETABLET12015
71335-0345-7Naproxen14 in 1 BOTTLETABLET1415
71335-0345-8Naproxen42 in 1 BOTTLETABLET4215
71335-0345-9Naproxen40 in 1 BOTTLETABLET4015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0345-0EA - Each71335-0345e9108425-42fc-4b6b-afbe-0ffcb75c8add12018-01-12
71335-0345-1EA - Each71335-0345605efb84-492d-43ba-8743-e4a6d82e2d2912018-01-12
71335-0345-2EA - Each71335-034598d6d5e2-24cd-4eb9-ab0a-90b6eb95547712018-01-12
71335-0345-3EA - Each71335-0345e6daac06-4ddc-42e4-b5f3-1d7525a90b0712018-01-12
71335-0345-4EA - Each71335-0345882ec939-2afa-433c-b2a7-56a2e790946a12018-01-12
71335-0345-5EA - Each71335-03458d393ff7-8f95-41ee-b693-8b055306aac512018-01-12
71335-0345-6EA - Each71335-03456f2cf45a-7cca-4360-abbb-0826b6cb246412018-01-12
71335-0345-7EA - Each71335-0345de94a539-7811-4a5e-99b8-f1711fe31d9412018-01-12
71335-0345-8EA - Each71335-034563fbaf24-1c82-46f8-93a5-9b3f7c2c19b812018-01-12
71335-0345-9EA - Each71335-03452792c010-b70e-4179-9917-79558413131f12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0345NAPROXEN TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 10 package rows20240822_a4f31070-4ee1-4d64-8b1d-40b9011e124b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNa4f31070-4ee1-4d64-8b1d-40b9011e124b15
198014naproxen 500 MG Oral TabletSCDa4f31070-4ee1-4d64-8b1d-40b9011e124b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0345-07133503450028 TABLET in 1 BOTTLE (71335-0345-0) 28 tablet2021-12-270000-00-00NoNoCurrent
71335-0345-17133503450130 TABLET in 1 BOTTLE (71335-0345-1) 30 tablet2018-06-130000-00-00NoNoCurrent
71335-0345-27133503450260 TABLET in 1 BOTTLE (71335-0345-2) 60 tablet2018-03-050000-00-00NoNoCurrent
71335-0345-37133503450310 TABLET in 1 BOTTLE (71335-0345-3) 10 tablet2018-04-060000-00-00NoNoCurrent
71335-0345-47133503450490 TABLET in 1 BOTTLE (71335-0345-4) 90 tablet2018-04-030000-00-00NoNoCurrent
71335-0345-57133503450520 TABLET in 1 BOTTLE (71335-0345-5) 20 tablet2018-04-030000-00-00NoNoCurrent
71335-0345-671335034506120 TABLET in 1 BOTTLE (71335-0345-6) 120 tablet2018-05-100000-00-00NoNoCurrent
71335-0345-77133503450714 TABLET in 1 BOTTLE (71335-0345-7) 14 tablet2018-02-280000-00-00NoNoCurrent
71335-0345-87133503450842 TABLET in 1 BOTTLE (71335-0345-8) 42 tablet2021-12-270000-00-00NoNoCurrent
71335-0345-97133503450940 TABLET in 1 BOTTLE (71335-0345-9) 40 tablet2018-07-120000-00-00NoNoCurrent