FDA.reportPublic FDA data

Naproxen

Product NDC
21695-085
11-digit product format
216950085
Labeler code
21695
Product ID
21695-085_a04bcc67-1f1a-4669-bb69-77738a939944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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
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
21695-085-202019-09-24C16284748780-1934fe258-48b4-48b1-e053-8cdaa90a720aNaproxen Tablets, USP
21695-085-302019-09-24C16284748780-1934fe258-48b4-48b1-e053-8cdaa90a720aNaproxen Tablets, USP
21695-085-602019-09-24C16284748780-1934fe258-48b4-48b1-e053-8cdaa90a720aNaproxen Tablets, USP
21695-085-722019-09-24C16284748780-1934fe258-48b4-48b1-e053-8cdaa90a720aNaproxen Tablets, USP
21695-085-902019-09-24C16284748780-1934fe258-48b4-48b1-e053-8cdaa90a720aNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-085-20Naproxen20 in 1 BOTTLETABLET203
21695-085-30Naproxen30 in 1 BOTTLETABLET303
21695-085-60Naproxen60 in 1 BOTTLETABLET603
21695-085-72Naproxen120 in 1 BOTTLETABLET1203
21695-085-90Naproxen90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-085-20EA - Each21695-08560648a63-2252-4a9c-a305-8573e888846012012-07-24
21695-085-30EA - Each21695-08566316fea-7f03-40c1-aabb-40462b52d19e12012-07-24
21695-085-60EA - Each21695-085be9dd415-90a2-4ce5-9758-ae92de39ede012012-07-24
21695-085-72EA - Each21695-085a65f9494-93a3-4213-bd31-157a53dbcf8112012-07-24
21695-085-90EA - Each21695-0859b502e71-8e45-445b-95cf-0f6812e95f3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-085NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3Legacy NDC, 5 package rows20111108_8c7b265e-7500-464a-854e-9c4a22c8d211.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198013naproxen 250 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-085-202169500852020 in 1 BOTTLEHistorical
21695-085-302169500853030 in 1 BOTTLEHistorical
21695-085-602169500856060 in 1 BOTTLEHistorical
21695-085-7221695008572120 in 1 BOTTLEHistorical
21695-085-902169500859090 in 1 BOTTLEHistorical