Naproxen

Product NDC
50844-271
11-digit product format
508440271
Labeler code
50844
Product ID
50844-271_785c9c93-2a92-4405-ae16-e3720ad506ad
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA079096
Marketing category
ANDA
Marketing start
2019-09-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-271-435084402714360 POUCH in 1 CARTON (50844-271-43) > 1 TABLET in 1 POUCH60 pouch2019-09-120000-00-00NoNoCurrent