Naproxen Sodium BACK AND MUSCLE PAIN

Product NDC
58602-739
11-digit product format
586020739
Labeler code
58602
Product ID
58602-739_ff1010cd-0fc3-4e54-8a03-f3dfa1417926
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA205497
Marketing category
ANDA
Marketing start
2021-07-14
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9TN87S3A3CNAPROXEN SODIUM26159-34-2NAPROXEN SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-739-07586020739071 BOTTLE in 1 CARTON (58602-739-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-12586020739121 BOTTLE in 1 CARTON (58602-739-12) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-19586020739191 BOTTLE in 1 CARTON (58602-739-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-02NoNoHistorical
58602-739-21586020739211 BOTTLE in 1 CARTON (58602-739-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-25586020739251 BOTTLE in 1 CARTON (58602-739-25) / 130 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-29586020739291 BOTTLE in 1 CARTON (58602-739-29) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-34586020739341 BOTTLE in 1 CARTON (58602-739-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-38586020739381 BOTTLE in 1 CARTON (58602-739-38) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-40586020739401 BOTTLE in 1 CARTON (58602-739-40) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical
58602-739-4458602073944400 TABLET, FILM COATED in 1 BOTTLE (58602-739-44) 2021-07-14NoNoHistorical
58602-739-78586020739781 BOTTLE in 1 CARTON (58602-739-78) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naproxen Sodium BACK AND MUSCLE PAIN - Aurohealth LLC | Aurobindo Pharma LimitedAurohealth LLC | Aurobindo Pharma Limited2025-05-26Human OTC Drug Label5