FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
11822-6040
11-digit product format
118226040
Labeler code
11822
Product ID
11822-6040_cade5181-be44-48b9-9c46-d29c48570efd
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA204872
Marketing category
ANDA
Marketing start
2022-07-18
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
Naproxen Sodium
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
11822-6040-2Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED17
11822-6040-2Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1007
11822-6040-5Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, FILM COATED507
11822-6040-5Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED17
11822-6040-6Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED17
11822-6040-6Naproxen Sodium200 in 1 BOTTLE, PLASTICTABLET, FILM COATED2007
11822-6040-7Naproxen Sodium270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2707
11822-6040-8Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED17
11822-6040-8Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, FILM COATED247
11822-6040-9Naproxen Sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED907
11822-6040-9Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6040NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION]5Current NDC, Legacy NDC, 11 package rows20240601_e6277515-c606-4535-9c29-08cade045aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNe6277515-c606-4535-9c29-08cade045aee7
849574naproxen sodium 220 MG Oral TabletSCDe6277515-c606-4535-9c29-08cade045aee7
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYe6277515-c606-4535-9c29-08cade045aee7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-6040-2118226040021 BOTTLE, PLASTIC in 1 CARTON (11822-6040-2) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-07-180000-00-00NoNoCurrent
11822-6040-5118226040051 BOTTLE, PLASTIC in 1 CARTON (11822-6040-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-07-180000-00-00NoNoCurrent
11822-6040-6118226040061 BOTTLE, PLASTIC in 1 CARTON (11822-6040-6) / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-07-180000-00-00NoNoCurrent
11822-6040-711822604007270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-6040-7) 2022-07-180000-00-00NoNoCurrent
11822-6040-8118226040081 BOTTLE, PLASTIC in 1 CARTON (11822-6040-8) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-07-180000-00-00NoNoCurrent
11822-6040-9118226040091 BOTTLE, PLASTIC in 1 CARTON (11822-6040-9) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-07-18NoNoHistorical