Naproxen

Product NDC
50090-6666
11-digit product format
500906666
Labeler code
50090
Product ID
50090-6666_e4ad6bc9-90ba-4e65-b323-14ecebff9912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200429
Marketing category
ANDA
Marketing start
2011-11-08
Substance
NAPROXEN
Active strength
500 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6666-05009066660015 TABLET in 1 BOTTLE (50090-6666-0) 15 tablet2023-08-31NoNoHistorical
50090-6666-15009066660120 TABLET in 1 BOTTLE (50090-6666-1) 20 tablet2023-08-31NoNoHistorical
50090-6666-25009066660230 TABLET in 1 BOTTLE (50090-6666-2) 30 tablet2023-08-31NoNoHistorical
50090-6666-45009066660414 TABLET in 1 BOTTLE (50090-6666-4) 14 tablet2023-08-31NoNoHistorical
50090-6666-55009066660540 TABLET in 1 BOTTLE (50090-6666-5) 40 tablet2023-08-31NoNoHistorical
50090-6666-650090666606100 TABLET in 1 BOTTLE (50090-6666-6) 100 tablet2023-08-31NoNoHistorical
50090-6666-75009066660760 TABLET in 1 BOTTLE (50090-6666-7) 60 tablet2023-08-31NoNoHistorical
50090-6666-9500906666096 TABLET in 1 BOTTLE (50090-6666-9) 6 tablet2023-08-31NoNoHistorical