IBUPROFEN

Product NDC
68210-0009
11-digit product format
682100009
Labeler code
68210
Product ID
68210-0009_ee03445d-01db-a710-e053-2995a90a57a2
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS,LLC
Application
ANDA079205
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
68210-0009-0682100009001 BOTTLE in 1 CARTON (68210-0009-0) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-11-220000-00-00NoNoCurrent
68210-0009-1682100009011 BOTTLE in 1 CARTON (68210-0009-1) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-11-220000-00-00NoNoCurrent
68210-0009-6682100009061 BOTTLE in 1 CARTON (68210-0009-6) > 6 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-10-240000-00-00NoNoCurrent