Naproxen Sodium

Product NDC
68071-4901
11-digit product format
680714901
Labeler code
68071
Product ID
68071-4901_bb91a9ef-413f-c934-e053-2a95a90a94a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200629
Marketing category
ANDA
Marketing start
2011-10-31
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4901-46807149010414 TABLET, FILM COATED in 1 BOTTLE (68071-4901-4) 2019-05-210000-00-00NoNoCurrent