All Day Pain Relief

Product NDC
55319-417
11-digit product format
553190417
Labeler code
55319
Product ID
55319-417_70633ba7-5467-46eb-8ef0-eeb2060cfb95
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Family Dollar Services Inc
Application
ANDA204872
Marketing category
ANDA
Marketing start
2017-01-23
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
55319-417-12553190417121 BOTTLE, PLASTIC in 1 CARTON (55319-417-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2017-01-230000-00-00NoNoCurrent
55319-417-62553190417621 BOTTLE in 1 CARTON (55319-417-62) > 15 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-01-230000-00-00NoNoCurrent