FDA.reportPublic FDA data

Naproxen

Product NDC
69238-1730
11-digit product format
692381730
Labeler code
69238
Product ID
69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212705
Marketing category
ANDA
Marketing start
2020-08-03
Substance
NAPROXEN
Active strength
25 mg/mL
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
NAPROXEN25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui311913

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1730-22024-12-18C16284748780-11030e365-10ad-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN ORAL SUSPENSION safely and effectively. See full prescribing information for NAPROXEN ORAL SUSPENSION. NAPROXEN oral suspension Initial U.S. Approval: 1976
69238-1730-22024-01-30C16284748780-11030e365-10ad-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN ORAL SUSPENSION safely and effectively. See full prescribing information for NAPROXEN ORAL SUSPENSION. NAPROXEN oral suspension Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1730-2Naproxen473 mL in 1 BOTTLESUSPENSION47310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1730-2ML - Milliliter69238-1730a4892b7a-dfe3-431c-911d-18b79bfd1ce212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1730NAPROXEN SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 1 package rows20241220_985aedc1-8b3c-4cb4-af13-7203a2b57ab7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311913naproxen 125 MG in 5 mL Oral SuspensionPSN985aedc1-8b3c-4cb4-af13-7203a2b57ab710
311913naproxen 25 MG/ML Oral SuspensionSCD985aedc1-8b3c-4cb4-af13-7203a2b57ab710
311913naproxen 125 MG per 5 ML Oral SuspensionSY985aedc1-8b3c-4cb4-af13-7203a2b57ab710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1730-269238173002473 mL in 1 BOTTLE (69238-1730-2) 473 ml2020-08-030000-00-00NoNoCurrent