FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
21695-090
11-digit product format
216950090
Labeler code
21695
Product ID
21695-090_0c01cb34-0d6b-4248-afde-82d4d934dabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
21695-090-142019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-202019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-282019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-302019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-562019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-602019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg
21695-090-902019-09-24C16284748780-1934fe258-4764-48b1-e053-8cdaa90a720aNaproxen Sodium Tablets, USP 275 mg and 550 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-090-14Naproxen Sodium14 in 1 BOTTLETABLET141
21695-090-20Naproxen Sodium20 in 1 BOTTLETABLET201
21695-090-28Naproxen Sodium28 in 1 BOTTLETABLET281
21695-090-30Naproxen Sodium30 in 1 BOTTLETABLET301
21695-090-56Naproxen Sodium56 in 1 BOTTLETABLET561
21695-090-60Naproxen Sodium60 in 1 BOTTLETABLET601
21695-090-90Naproxen Sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-090-14EA - Each21695-0901eb70789-bc25-497e-9158-1d2951bdbc4e12012-07-24
21695-090-20EA - Each21695-090a21c208b-3779-4df7-a431-206533b1191212012-07-24
21695-090-28EA - Each21695-090ae76e7c9-99bb-4a86-9f0c-2a9c87faf15612012-07-24
21695-090-30EA - Each21695-090d535edae-350e-4b3a-b49c-7218f1cdf40e12012-07-24
21695-090-56EA - Each21695-090c67aba18-fab0-420e-8e8d-f7b089bd6b0b12012-07-24
21695-090-60EA - Each21695-090f9e518fe-aa6f-4d6f-9681-e75fc565d4fd12012-07-24
21695-090-90EA - Each21695-0905063a2a7-5a58-4389-8e57-f5af4f04ecfb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-090NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 7 package rows20110314_0c01cb34-0d6b-4248-afde-82d4d934dabd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN0c01cb34-0d6b-4248-afde-82d4d934dabd1
849431naproxen sodium 550 MG Oral TabletSCD0c01cb34-0d6b-4248-afde-82d4d934dabd1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY0c01cb34-0d6b-4248-afde-82d4d934dabd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-090-142169500901414 in 1 BOTTLEHistorical
21695-090-202169500902020 in 1 BOTTLEHistorical
21695-090-282169500902828 in 1 BOTTLEHistorical
21695-090-302169500903030 in 1 BOTTLEHistorical
21695-090-562169500905656 in 1 BOTTLEHistorical
21695-090-602169500906060 in 1 BOTTLEHistorical
21695-090-902169500909090 in 1 BOTTLEHistorical