Assured Ibuprofen

Product NDC
68210-0011
11-digit product format
682100011
Labeler code
68210
Product ID
68210-0011_ee034c43-069d-2a71-e053-2a95a90a42fc
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
ANDA202312
Marketing category
ANDA
Marketing start
2019-02-25
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
68210-0011-4682100011041 BOTTLE in 1 CARTON (68210-0011-4) > 40 TABLET in 1 BOTTLE1 bottle2019-02-250000-00-00NoNoCurrent