Naproxen

Product NDC
42291-629
11-digit product format
422910629
Labeler code
42291
Product ID
42291-629_c83295f4-d998-4ade-a186-ed91ced4abe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA091432
Marketing category
ANDA
Marketing start
2013-10-24
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-629-012022-02-05C16284748780-1d6a99b39-ed72-a426-e053-dadaa90af4c2d17048e2-02a9-d33f-f129-154e36213fdd
42291-629-012022-01-28C16284748780-1d6a99b39-ed72-a426-e053-dadaa90af4c2d17048e2-02a9-d33f-f129-154e36213fdd

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-629-01EA - Each42291-629d4c10712-c27f-4ab4-b235-e7d7e8b4623912014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-629-0142291062901100 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-629-01) 2013-10-240000-00-00NoNoCurrent