Assured Ibuprofen

Product NDC
68210-0080
11-digit product format
682100080
Labeler code
68210
Product ID
68210-0080_ee03445d-01dc-a710-e053-2995a90a57a2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
ANDA091239
Marketing category
ANDA
Marketing start
2017-11-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0080-3682100080031 BOTTLE in 1 CARTON (68210-0080-3) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-10-310000-00-00NoNoCurrent
68210-0080-6682100080061 BOTTLE in 1 CARTON (68210-0080-6) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-12-220000-00-00NoNoCurrent