First Aid Direct Naproxen Sodium

Product NDC
42961-108
11-digit product format
429610108
Labeler code
42961
Product ID
42961-108_3455dc97-bf78-4fa7-ab79-a0c46633d8b7
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cintas Corp
Application
ANDA079096
Marketing category
ANDA
Marketing start
2022-01-24
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
42961-108-024296101080225 PACKET in 1 CARTON (42961-108-02) > 1 TABLET, COATED in 1 PACKET (42961-108-01) 25 packet2022-01-310000-00-00NoNoCurrent