FDA.reportPublic FDA data

rugby all day relief

Product NDC
0536-1094
11-digit product format
005361094
Labeler code
0536
Product ID
0536-1094_d7f82128-5f85-4af6-9ba8-4279725ca3ef
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA074661
Marketing category
ANDA
Marketing start
2015-09-02
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
rugby all day relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1094-01rugby all day relief100 in 1 BOTTLETABLET, FILM COATED1007
0536-1094-01rugby all day relief1 in 1 CARTONTABLET, FILM COATED17
0536-1094-06rugby all day relief50 in 1 BOTTLETABLET, FILM COATED507
0536-1094-06rugby all day relief1 in 1 CARTONTABLET, FILM COATED17
0536-1094-11rugby all day relief90 in 1 BOTTLETABLET, FILM COATED907
0536-1094-11rugby all day relief1 in 1 CARTONTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1094-01EA - Each0536-10945f14cbac-83d0-4ab1-b342-5019c5b373b312016-01-13
0536-1094-06EA - Each0536-10942a06bf0d-87a9-4309-b9bd-8813cc21f6a912015-10-02
0536-1094-11EA - Each0536-1094c397cacc-4615-438b-aa5b-1b5e1ab2268d12022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
NAPROXENACTIVE MOIETY57Y76R9ATQRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ERUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1094RUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 6 package rows20240912_f587a428-291c-4c54-80fe-244a961b0521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN369f5123-283d-4aa6-8861-8d183f2ba94d7
849574naproxen sodium 220 MG Oral TabletPSNf587a428-291c-4c54-80fe-244a961b05217
849574naproxen sodium 220 MG Oral TabletSCD369f5123-283d-4aa6-8861-8d183f2ba94d7
849574naproxen sodium 220 MG Oral TabletSCDf587a428-291c-4c54-80fe-244a961b05217
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY369f5123-283d-4aa6-8861-8d183f2ba94d7
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf587a428-291c-4c54-80fe-244a961b05217
849574naproxen sodium 220 MG Oral TabletPSN7d788121-ed7d-4294-e053-2a91aa0a3cd32
849574naproxen sodium 220 MG Oral TabletSCD7d788121-ed7d-4294-e053-2a91aa0a3cd32
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY7d788121-ed7d-4294-e053-2a91aa0a3cd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1094-01005361094011 BOTTLE in 1 CARTON (0536-1094-01) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-020000-00-00NoNoCurrent
0536-1094-06005361094061 BOTTLE in 1 CARTON (0536-1094-06) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-020000-00-00NoNoCurrent
0536-1094-11005361094111 BOTTLE in 1 CARTON (0536-1094-11) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-270000-00-00NoNoCurrent