NAPROXEN SODIUM

Product NDC
68210-0400
11-digit product format
682100400
Labeler code
68210
Product ID
68210-0400_d2048522-dc5e-715c-e053-2995a90abba1
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS,LLC
Application
ANDA090545
Marketing category
ANDA
Marketing start
2017-11-22
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0400-0682100400001 BOTTLE in 1 CARTON (68210-0400-0) > 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-12-220000-00-00NoNoCurrent
68210-0400-1682100400011 BOTTLE in 1 CARTON (68210-0400-1) > 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-11-220000-00-00NoNoCurrent