Ibuprofen

Product NDC
63868-779
11-digit product format
638680779
Labeler code
63868
Product ID
63868-779_560679f3-86ef-4332-90a3-b2d92667ac53
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA074916
Marketing category
ANDA
Marketing start
2018-03-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-779-04ML - Milliliter63868-77918a97007-1e8e-4e39-88e3-8b963ac1816712019-08-06
63868-779-08ML - Milliliter63868-7796ae784d2-38ca-4070-a3e8-f0a34be9578212019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-779-04638680779041 BOTTLE in 1 CARTON (63868-779-04) > 118 mL in 1 BOTTLE1 bottle2019-01-250000-00-00NoNoCurrent
63868-779-08638680779081 BOTTLE in 1 CARTON (63868-779-08) > 237 mL in 1 BOTTLE1 bottle2018-03-220000-00-00NoNoCurrent