Naproxen Sodium

Product NDC
51316-417
11-digit product format
513160417
Labeler code
51316
Product ID
51316-417_01b06900-15bc-4867-a347-d5f0101d4fb8
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA204872
Marketing category
ANDA
Marketing start
2021-11-04
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-417-08513160417081 BOTTLE, PLASTIC in 1 CARTON (51316-417-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-11-040000-00-00NoNoCurrent
51316-417-15513160417151 BOTTLE, PLASTIC in 1 CARTON (51316-417-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-11-040000-00-00NoNoCurrent