Naproxen Sodium

Product NDC
52605-141
11-digit product format
526050141
Labeler code
52605
Product ID
52605-141_b06d4755-1fbf-4fcf-9075-cb1691292aad
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Polygen Pharmaceuticals LLC
Application
ANDA090545
Marketing category
ANDA
Marketing start
2012-06-11
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
52605-141-012021-01-29C16284748780-19855d018-e3d2-cd31-e053-dbdaa90ab51aNaproxen Sodium Tablets, USP 220 mg
52605-141-012019-11-27C16284748780-19855d018-e3d2-cd31-e053-dbdaa90ab51aNaproxen Sodium Tablets, USP 220 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52605-141-01Naproxen Sodium1 in 1 CARTONTABLET, COATED16
52605-141-01Naproxen Sodium100 in 1 BOTTLETABLET, COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-141NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20130626_e8720904-9ac0-46c0-b220-730e373505a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNe8720904-9ac0-46c0-b220-730e373505a76
849574naproxen sodium 220 MG Oral TabletSCDe8720904-9ac0-46c0-b220-730e373505a76
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYe8720904-9ac0-46c0-b220-730e373505a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52605-141-01526050141011 in 1 CARTONHistorical