CAREALL Naproxen Sodium

Product NDC
51824-109
11-digit product format
518240109
Labeler code
51824
Product ID
51824-109_44ebec12-b291-744a-e063-6394a90a2dd8
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
New World Imports, Inc.
Application
ANDA079096
Marketing category
ANDA
Marketing start
2024-08-23
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
CAREALL Naproxen Sodium
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
51824-109-01CAREALL Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-109CAREALL NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [NEW WORLD IMPORTS, INC.]1Current NDC, 1 package rows20240824_3952324e-77f4-4117-a97a-ab5651130058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN3952324e-77f4-4117-a97a-ab56511300582
849574naproxen sodium 220 MG Oral TabletSCD3952324e-77f4-4117-a97a-ab56511300582
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY3952324e-77f4-4117-a97a-ab56511300582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-109-0151824010901100 TABLET in 1 BOTTLE, PLASTIC (51824-109-01) 100 tablet2024-08-23NoNoHistorical