FDA.reportPublic FDA data

Naproxen sodium

Product NDC
55700-625
11-digit product format
557000625
Labeler code
55700
Product ID
55700-625_2246167b-966d-45d9-96e7-adab65c3792c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078486
Marketing category
ANDA
Marketing start
2018-05-18
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen sodium

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
55700-625-30Naproxen sodium30 in 1 BOTTLETABLET, FILM COATED3010
55700-625-60Naproxen sodium60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-625NAPROXEN SODIUM TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]10Current NDC, Legacy NDC, 2 package rows20250101_e2ed5556-8109-4002-bf8b-827518a84ea4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNe2ed5556-8109-4002-bf8b-827518a84ea410
849431naproxen sodium 550 MG Oral TabletSCDe2ed5556-8109-4002-bf8b-827518a84ea410
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYe2ed5556-8109-4002-bf8b-827518a84ea410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-625-305570006253030 TABLET, FILM COATED in 1 BOTTLE (55700-625-30) 2018-05-180000-00-00NoNoCurrent
55700-625-605570006256060 TABLET, FILM COATED in 1 BOTTLE (55700-625-60) 2020-12-022026-10-31NoNoCurrent