FDA.reportPublic FDA data

Naproxen

Product NDC
0440-7852
11-digit product format
004407852
Labeler code
0440
Product ID
0440-7852_89ada3cc-d634-43fd-a873-a912d2c9ecd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
0440-7852-142020-01-31C16284748780-19d75b9d0-939a-f424-e053-dadaa90a57ceNaproxen Tablets, USP
0440-7852-202020-01-31C16284748780-19d75b9d0-939a-f424-e053-dadaa90a57ceNaproxen Tablets, USP
0440-7852-302020-01-31C16284748780-19d75b9d0-939a-f424-e053-dadaa90a57ceNaproxen Tablets, USP
0440-7852-602020-01-31C16284748780-19d75b9d0-939a-f424-e053-dadaa90a57ceNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7852-14Naproxen14 in 1 BOTTLETABLET141
0440-7852-20Naproxen20 in 1 BOTTLETABLET201
0440-7852-30Naproxen30 in 1 BOTTLETABLET301
0440-7852-60Naproxen60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-7852-20EA - Each0440-785296d88284-4f5f-4546-a04a-1bba5c2284cd12017-05-03
0440-7852-30EA - Each0440-78525bf459e6-7b1a-4fdc-be32-74633c33890d12017-05-03
0440-7852-60EA - Each0440-78523ef9a783-c2d5-4e28-91c5-301d85d615b512015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7852NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20121024_4054e004-de40-4e51-bd37-ce9d04eef164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN4054e004-de40-4e51-bd37-ce9d04eef1641
198014naproxen 500 MG Oral TabletSCD4054e004-de40-4e51-bd37-ce9d04eef1641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7852-140044078521414 in 1 BOTTLEHistorical
0440-7852-200044078522020 in 1 BOTTLEHistorical
0440-7852-300044078523030 in 1 BOTTLEHistorical
0440-7852-600044078526060 in 1 BOTTLEHistorical