FDA.reportPublic FDA data

Naproxen

Product NDC
71205-060
11-digit product format
712050060
Labeler code
71205
Product ID
71205-060_6b4c9ec2-308f-4b60-941c-34a2c7a7882c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
Substance
NAPROXEN
Active strength
375 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
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui603103

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
71205-060-14Naproxen14 in 1 BOTTLETABLET, DELAYED RELEASE143
71205-060-15Naproxen15 in 1 BOTTLETABLET, DELAYED RELEASE153
71205-060-20Naproxen20 in 1 BOTTLETABLET, DELAYED RELEASE203
71205-060-30Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE303
71205-060-40Naproxen40 in 1 BOTTLETABLET, DELAYED RELEASE403
71205-060-45Naproxen45 in 1 BOTTLETABLET, DELAYED RELEASE453
71205-060-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE603
71205-060-90Naproxen90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-060-60EA - Each71205-060bf31b714-79a7-4758-af9a-34b7eed4e27812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-060NAPROXEN TABLET, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 8 package rows20191030_69a3afd6-d64b-4f07-b848-b0d3fc19f2a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSN69a3afd6-d64b-4f07-b848-b0d3fc19f2a23
603103naproxen 375 MG Delayed Release Oral TabletSCD69a3afd6-d64b-4f07-b848-b0d3fc19f2a23
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY69a3afd6-d64b-4f07-b848-b0d3fc19f2a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-060-147120500601414 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-14) 2018-06-010000-00-00NoNoCurrent
71205-060-157120500601515 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-15) 2018-06-010000-00-00NoNoCurrent
71205-060-207120500602020 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-20) 2018-06-010000-00-00NoNoCurrent
71205-060-307120500603030 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-30) 2018-06-010000-00-00NoNoCurrent
71205-060-407120500604040 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-40) 2018-06-010000-00-00NoNoCurrent
71205-060-457120500604545 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-45) 2018-06-010000-00-00NoNoCurrent
71205-060-607120500606060 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-60) 2018-06-010000-00-00NoNoCurrent
71205-060-907120500609090 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-90) 2018-06-010000-00-00NoNoCurrent