FDA.reportPublic FDA data

PROXEN NP 660

Product NDC
69729-123
11-digit product format
697290123
Labeler code
69729
Product ID
69729-123_0d811063-82c1-bf9f-e063-6294a90aa371
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
OPMX LLC
Application
ANDA091353
Marketing category
ANDA
Marketing start
2023-11-07
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
PROXEN NP 660
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
69729-123-12PROXEN NP 66012 in 1 BLISTER PACKTABLET123
69729-123-12PROXEN NP 6601 in 1 CARTONTABLET13
69729-123-24PROXEN NP 66012 in 1 BLISTER PACKTABLET123
69729-123-24PROXEN NP 6602 in 1 CARTONTABLET23
69729-123-50PROXEN NP 66050 in 1 CARTONTABLET503
69729-123-50PROXEN NP 6602 in 1 POUCHTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-123PROXEN NP 660 (NAPROXEN SODIUM) TABLET [OPMX LLC]3Current NDC, 6 package rows20231228_09990b2f-202e-b4df-e063-6394a90a055b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN09990b2f-202e-b4df-e063-6394a90a055b3
849574naproxen sodium 220 MG Oral TabletSCD09990b2f-202e-b4df-e063-6394a90a055b3
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY09990b2f-202e-b4df-e063-6394a90a055b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69729-123-12697290123121 BLISTER PACK in 1 CARTON (69729-123-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2023-11-07NoNoCurrent
69729-123-24697290123242 BLISTER PACK in 1 CARTON (69729-123-24) / 12 TABLET in 1 BLISTER PACK2 blister pack2023-11-16NoNoCurrent
69729-123-506972901235050 POUCH in 1 CARTON (69729-123-50) / 2 TABLET in 1 POUCH50 pouch2023-11-07NoNoCurrent