FDA.reportPublic FDA data

Naproxen Sodium PM

Product NDC
62011-0396
11-digit product format
620110396
Labeler code
62011
Product ID
62011-0396_d3f5df98-41db-4d8f-b8e7-10959d821a04
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA209726
Marketing category
ANDA
Marketing start
2019-01-31
Marketing end
2027-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25; 220 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium PM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, 9TN87S3A3C
Rxcui1550957

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0396-1Naproxen Sodium PM20 in 1 BOTTLE, PLASTICTABLET204
62011-0396-1Naproxen Sodium PM1 in 1 BOXTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0396NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20221116_7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba4
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62011-0396-1620110396011 BOTTLE, PLASTIC in 1 BOX (62011-0396-1) / 20 TABLET in 1 BOTTLE, PLASTIC2019-01-312027-01-31NoNoCurrent