FDA.reportPublic FDA data

NAPRELAN

Product NDC
21695-906
11-digit product format
216950906
Labeler code
21695
Product ID
21695-906_1f949140-68b5-4602-936f-1936e436d553
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020353
Marketing category
NDA
Marketing start
1996-01-05
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-906-602019-09-24C16284748780-1934fe258-471c-48b1-e053-8cdaa90a720aNAPRELAN ® (naproxen sodium) CONTROLLED-RELEASE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-906-60NAPRELAN60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-906-60EA - Each21695-9066a99d3f5-d970-4b12-9fc1-7887974a2e7012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
naproxen sodiumACTIVE INGREDIENT9TN87S3A3CNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
naproxenACTIVE MOIETY57Y76R9ATQNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ANAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94ENAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-906NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110104_1f949140-68b5-4602-936f-1936e436d553.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116331NAPRELAN 375 MG 24HR Extended Release Oral TabletPSN1f949140-68b5-4602-936f-1936e436d5531
1116341NAPRELAN 500 MG 24HR Extended Release Oral TabletPSN1f949140-68b5-4602-936f-1936e436d5531
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSN1f949140-68b5-4602-936f-1936e436d5531
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSN1f949140-68b5-4602-936f-1936e436d5531
111633124 HR naproxen 375 MG Extended Release Oral Tablet [Naprelan]SBD1f949140-68b5-4602-936f-1936e436d5531
111634124 HR naproxen 500 MG Extended Release Oral Tablet [Naprelan]SBD1f949140-68b5-4602-936f-1936e436d5531
111632024 HR naproxen 375 MG Extended Release Oral TabletSCD1f949140-68b5-4602-936f-1936e436d5531
111633924 HR naproxen 500 MG Extended Release Oral TabletSCD1f949140-68b5-4602-936f-1936e436d5531
111633124 HR Naprelan 375 MG Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531
111634124 HR Naprelan 500 MG Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531
1116331Naprelan 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531
1116341Naprelan 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSY1f949140-68b5-4602-936f-1936e436d5531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-906-602169509066060 in 1 BOTTLEHistorical