FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
63941-445
11-digit product format
639410445
Labeler code
63941
Product ID
63941-445_45b2f845-70cf-84e9-e063-6394a90a563e
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
ANDA079096
Marketing category
ANDA
Marketing start
2024-05-01
Marketing end
2028-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-445-01Naproxen Sodium1 in 1 CARTONTABLET, COATED13
63941-445-01Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, COATED243
63941-445-02Naproxen Sodium1 in 1 CARTONTABLET, COATED13
63941-445-02Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED503
63941-445-03Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, COATED1003
63941-445-03Naproxen Sodium1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-445NAPROXEN SODIUM TABLET, COATED [VALU MERCHANDISERS COMPANY]2Current NDC, 6 package rows20240615_1274889d-803c-d7fd-e063-6394a90ab9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN1274889d-803c-d7fd-e063-6394a90ab9a83
849574naproxen sodium 220 MG Oral TabletSCD1274889d-803c-d7fd-e063-6394a90ab9a83
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1274889d-803c-d7fd-e063-6394a90ab9a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-445-01639410445011 BOTTLE, PLASTIC in 1 CARTON (63941-445-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2024-05-012028-03-31NoNoHistorical
63941-445-02639410445021 BOTTLE, PLASTIC in 1 CARTON (63941-445-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2024-05-012028-03-31NoNoHistorical
63941-445-03639410445031 BOTTLE, PLASTIC in 1 CARTON (63941-445-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2024-05-012028-06-30NoNoHistorical