FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
47781-153
11-digit product format
477810153
Labeler code
47781
Product ID
47781-153_6a207289-a8f0-9db1-548f-b55af6131677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA020353
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-03-11
Marketing end
2027-07-31
Substance
NAPROXEN SODIUM
Active strength
375 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 SODIUM375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1116320, 1116339, 1116349

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
47781-153-012024-01-30C16284748780-11030e365-45d8-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS . NAPROXEN SODIUM Controlled-Release Tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-153-01Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-153-01EA - Each47781-153a1852f7f-cb1b-4fe9-850d-6819eea0848012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-153NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]10Current NDC, Legacy NDC, 1 package rows20240723_9225acaa-209f-958b-2c51-9a46995dec33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSN9225acaa-209f-958b-2c51-9a46995dec3311
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSN9225acaa-209f-958b-2c51-9a46995dec3311
1116349naproxen sodium 750 MG 24HR Extended Release Oral TabletPSN9225acaa-209f-958b-2c51-9a46995dec3311
111632024 HR naproxen 375 MG Extended Release Oral TabletSCD9225acaa-209f-958b-2c51-9a46995dec3311
111633924 HR naproxen 500 MG Extended Release Oral TabletSCD9225acaa-209f-958b-2c51-9a46995dec3311
111634924 HR naproxen 750 MG Extended Release Oral TabletSCD9225acaa-209f-958b-2c51-9a46995dec3311
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSY9225acaa-209f-958b-2c51-9a46995dec3311
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSY9225acaa-209f-958b-2c51-9a46995dec3311
1116349naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSY9225acaa-209f-958b-2c51-9a46995dec3311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-153-0147781015301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01) 2015-03-112027-07-31NoNoCurrent