FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
71205-631
11-digit product format
712050631
Labeler code
71205
Product ID
71205-631_0c969467-9318-4dd2-945e-95ec8092a0fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212199
Marketing category
ANDA
Marketing start
2019-10-30
Substance
NAPROXEN SODIUM
Active strength
550 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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849431

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
71205-631-15Naproxen Sodium15 in 1 BOTTLETABLET152
71205-631-30Naproxen Sodium30 in 1 BOTTLETABLET302
71205-631-60Naproxen Sodium60 in 1 BOTTLETABLET602
71205-631-90Naproxen Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-631-15EA - Each71205-6318139c2cb-92c2-480e-a55f-1a1c672b2a6312022-03-09
71205-631-30EA - Each71205-6318cde1e4b-242e-4ab5-aca8-d4e109aa6ab912022-12-07
71205-631-60EA - Each71205-6310d1ccabf-924c-4eee-9d1a-0471ad90447e12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-631NAPROXEN SODIUM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220715_a90bfc07-d01e-427c-b2df-41bff7612d2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG Oral TabletSCDa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYa90bfc07-d01e-427c-b2df-41bff7612d2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-631-157120506311515 TABLET in 1 BOTTLE (71205-631-15) 15 tablet2022-01-200000-00-00NoNoCurrent
71205-631-307120506313030 TABLET in 1 BOTTLE (71205-631-30) 30 tablet2022-01-200000-00-00NoNoCurrent
71205-631-607120506316060 TABLET in 1 BOTTLE (71205-631-60) 60 tablet2022-01-200000-00-00NoNoCurrent
71205-631-907120506319090 TABLET in 1 BOTTLE (71205-631-90) 90 tablet2022-01-200000-00-00NoNoCurrent