Naproxen Sodium

Product NDC
42291-532
11-digit product format
422910532
Labeler code
42291
Product ID
42291-532_9c5dc336-0fca-f335-e053-2995a90ad50b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA078432
Marketing category
ANDA
Marketing start
2009-10-21
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-532-01EA - Each42291-53289b86b61-869b-47df-bb9c-a019faf35e0812013-02-13
42291-532-50EA - Each42291-532d4f166f1-05f9-4818-9aad-e6130d25ff5e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-532-0142291053201100 TABLET in 1 BOTTLE (42291-532-01) 100 tablet2013-01-090000-00-00NoNoCurrent
42291-532-5042291053250500 TABLET in 1 BOTTLE (42291-532-50) 500 tablet2009-10-210000-00-00NoNoCurrent