FDA.reportPublic FDA data

Naproxen sodium

Product NDC
69230-329
11-digit product format
692300329
Labeler code
69230
Product ID
69230-329_ee21e0f7-9f32-6c63-e053-2a95a90ac996
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA211065
Marketing category
ANDA
Marketing start
2022-10-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen sodium
Listing expiration
2026-12-31

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
69230-329-01Naproxen sodium1 in 1 CARTONTABLET, FILM COATED11
69230-329-01Naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1001
69230-329-02Naproxen sodium200 in 1 BOTTLETABLET, FILM COATED2001
69230-329-02Naproxen sodium1 in 1 CARTONTABLET, FILM COATED11
69230-329-05Naproxen sodium500 in 1 BOTTLETABLET, FILM COATED5001
69230-329-10Naproxen sodium1000 in 1 BOTTLETABLET, FILM COATED10001
69230-329-24Naproxen sodium1 in 1 CARTONTABLET, FILM COATED11
69230-329-24Naproxen sodium24 in 1 BOTTLETABLET, FILM COATED241
69230-329-50Naproxen sodium1 in 1 CARTONTABLET, FILM COATED11
69230-329-50Naproxen sodium50 in 1 BOTTLETABLET, FILM COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-329-01EA - Each69230-329fd627f45-a13f-4396-84f4-b4b69983f36012024-11-05
69230-329-02EA - Each69230-329ef3f06d5-bc6b-4d25-b1ab-c1285767f0db12024-11-05
69230-329-05EA - Each69230-329dbc9531a-3820-4b86-b664-e03ebd51fcdf12024-11-05
69230-329-10EA - Each69230-329566aaf30-4f7b-4588-9138-cb532e65719612024-11-05
69230-329-24EA - Each69230-329e50f2523-92b6-464e-853f-b11eef777ef912024-11-05
69230-329-50EA - Each69230-32981c17919-7b71-49f0-972b-770460580a7512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-329NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [CAMBER CONSUMER CARE INC]1Current NDC, Legacy NDC, 10 package rows20221124_d1008e19-ff0d-4ed2-909d-bae5a82a1234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNd1008e19-ff0d-4ed2-909d-bae5a82a12341
849574naproxen sodium 220 MG Oral TabletSCDd1008e19-ff0d-4ed2-909d-bae5a82a12341
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYd1008e19-ff0d-4ed2-909d-bae5a82a12341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-329-01692300329011 BOTTLE in 1 CARTON (69230-329-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-10-280000-00-00NoNoCurrent
69230-329-02692300329021 BOTTLE in 1 CARTON (69230-329-02) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-10-280000-00-00NoNoCurrent
69230-329-0569230032905500 TABLET, FILM COATED in 1 BOTTLE (69230-329-05) 2022-10-280000-00-00NoNoCurrent
69230-329-10692300329101000 TABLET, FILM COATED in 1 BOTTLE (69230-329-10) 2022-10-280000-00-00NoNoCurrent
69230-329-24692300329241 BOTTLE in 1 CARTON (69230-329-24) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-10-280000-00-00NoNoCurrent
69230-329-50692300329501 BOTTLE in 1 CARTON (69230-329-50) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-10-280000-00-00NoNoCurrent