Naproxen Sodium

Product NDC
68788-7800
11-digit product format
687887800
Labeler code
68788
Product ID
68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212199
Marketing category
ANDA
Marketing start
2020-10-13
Substance
NAPROXEN SODIUM
Active strength
550 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 SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849431

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
68788-7800-1Naproxen Sodium100 in 1 BOTTLETABLET1005
68788-7800-2Naproxen Sodium20 in 1 BOTTLETABLET205
68788-7800-3Naproxen Sodium30 in 1 BOTTLETABLET305
68788-7800-4Naproxen Sodium14 in 1 BOTTLETABLET145
68788-7800-6Naproxen Sodium60 in 1 BOTTLETABLET605
68788-7800-8Naproxen Sodium120 in 1 BOTTLETABLET1205
68788-7800-9Naproxen Sodium90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7800NAPROXEN SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 7 package rows20240724_6ae413ba-5a48-423f-8b8d-7a42661cf836.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN6ae413ba-5a48-423f-8b8d-7a42661cf8365
849431naproxen sodium 550 MG Oral TabletSCD6ae413ba-5a48-423f-8b8d-7a42661cf8365
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY6ae413ba-5a48-423f-8b8d-7a42661cf8365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7800-168788780001100 TABLET in 1 BOTTLE (68788-7800-1) 100 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-26878878000220 TABLET in 1 BOTTLE (68788-7800-2) 20 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-36878878000330 TABLET in 1 BOTTLE (68788-7800-3) 30 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-46878878000414 TABLET in 1 BOTTLE (68788-7800-4) 14 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-66878878000660 TABLET in 1 BOTTLE (68788-7800-6) 60 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-868788780008120 TABLET in 1 BOTTLE (68788-7800-8) 120 tablet2020-10-130000-00-00NoNoCurrent
68788-7800-96878878000990 TABLET in 1 BOTTLE (68788-7800-9) 90 tablet2020-10-130000-00-00NoNoCurrent