Naproxen

Product NDC
71205-597
11-digit product format
712050597
Labeler code
71205
Product ID
71205-597_58d04fa7-f30f-4f9e-834c-f63b2c0431a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
57Y76R9ATQNAPROXEN22204-53-1NAPROXEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-597-107120505971010 TABLET in 1 BOTTLE (71205-597-10) 10 tablet2021-08-06NoNoHistorical
71205-597-147120505971414 TABLET in 1 BOTTLE (71205-597-14) 14 tablet2021-08-26NoNoHistorical
71205-597-157120505971515 TABLET in 1 BOTTLE (71205-597-15) 15 tablet2022-11-07NoNoHistorical
71205-597-207120505972020 TABLET in 1 BOTTLE (71205-597-20) 20 tablet2021-09-20NoNoHistorical
71205-597-307120505973030 TABLET in 1 BOTTLE (71205-597-30) 30 tablet2021-08-04NoNoHistorical
71205-597-407120505974040 TABLET in 1 BOTTLE (71205-597-40) 40 tablet2021-11-24NoNoHistorical
71205-597-607120505976060 TABLET in 1 BOTTLE (71205-597-60) 60 tablet2021-08-04NoNoHistorical
71205-597-907120505979090 TABLET in 1 BOTTLE (71205-597-90) 90 tablet2021-08-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NaproxenProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL6