Childrens Ibuprofen

Product NDC
63868-795
11-digit product format
638680795
Labeler code
63868
Product ID
63868-795_e30f7f75-b812-4dcb-9239-d26dd411ac08
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA210602
Marketing category
ANDA
Marketing start
2020-12-15
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-795-04ML - Milliliter63868-79514c79a9a-d229-44c3-8370-e3e47ba3624412022-09-12
63868-795-08ML - Milliliter63868-795d60d5af0-8eaa-4f0f-bdf4-3ca92cb4d8aa12022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-795-04638680795041 BOTTLE in 1 CARTON (63868-795-04) > 118 mL in 1 BOTTLE1 bottle2020-12-150000-00-00NoNoCurrent
63868-795-08638680795081 BOTTLE in 1 CARTON (63868-795-08) > 237 mL in 1 BOTTLE1 bottle2020-12-150000-00-00NoNoCurrent