FDA.reportPublic FDA data

Naproxen

Product NDC
71335-1282
11-digit product format
713351282
Labeler code
71335
Product ID
71335-1282_1245c4fb-1cb1-42f8-962d-f059c222ed3f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204872
Marketing category
ANDA
Marketing start
2019-01-01
Substance
NAPROXEN SODIUM
Active strength
220 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
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
71335-1282-1Naproxen20 in 1 BOTTLETABLET20103
71335-1282-2Naproxen30 in 1 BOTTLETABLET30103
71335-1282-3Naproxen40 in 1 BOTTLETABLET40103
71335-1282-4Naproxen50 in 1 BOTTLETABLET50103
71335-1282-5Naproxen60 in 1 BOTTLETABLET60103
71335-1282-6Naproxen14 in 1 BOTTLETABLET14103
71335-1282-7Naproxen100 in 1 BOTTLETABLET100103
71335-1282-8Naproxen90 in 1 BOTTLETABLET90103
71335-1282-9Naproxen24 in 1 BOTTLETABLET24103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1282-2EA - Each71335-1282a88647e8-bbbb-4f6d-ae70-f2d8d77a4b5112022-07-06
71335-1282-7EA - Each71335-1282a3b47e0c-7824-4a11-b610-00ecf7b07f0212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1282NAPROXEN (NAPROXEN SODIUM) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20250224_f9ddc614-26b7-48dc-ae93-02da6388f2d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNf9ddc614-26b7-48dc-ae93-02da6388f2d5103
849574naproxen sodium 220 MG Oral TabletSCDf9ddc614-26b7-48dc-ae93-02da6388f2d5103
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf9ddc614-26b7-48dc-ae93-02da6388f2d5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1282-17133512820120 TABLET in 1 BOTTLE (71335-1282-1) 20 tablet2021-11-180000-00-00NoNoCurrent
71335-1282-27133512820230 TABLET in 1 BOTTLE (71335-1282-2) 30 tablet2019-08-270000-00-00NoNoCurrent
71335-1282-37133512820340 TABLET in 1 BOTTLE (71335-1282-3) 40 tablet2019-10-220000-00-00NoNoCurrent
71335-1282-47133512820450 TABLET in 1 BOTTLE (71335-1282-4) 50 tablet2025-01-100000-00-00NoNoCurrent
71335-1282-57133512820560 TABLET in 1 BOTTLE (71335-1282-5) 60 tablet2025-01-300000-00-00NoNoCurrent
71335-1282-67133512820614 TABLET in 1 BOTTLE (71335-1282-6) 14 tablet2019-11-260000-00-00NoNoCurrent
71335-1282-771335128207100 TABLET in 1 BOTTLE (71335-1282-7) 100 tablet2019-10-250000-00-00NoNoCurrent
71335-1282-87133512820890 TABLET in 1 BOTTLE (71335-1282-8) 90 tablet2025-01-300000-00-00NoNoCurrent
71335-1282-97133512820924 TABLET in 1 BOTTLE (71335-1282-9) 24 tablet2025-01-300000-00-00NoNoCurrent