Childrens Novufen Ibuprofen

Product NDC
78307-100
11-digit product format
783070100
Labeler code
78307
Product ID
78307-100_a974aa0e-2e02-2c7d-e053-2a95a90a57d9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
NOVUGEN PHARMA LLC
Application
NDA020516
Marketing category
NDA
Marketing start
2020-07-03
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78307-100-01783070100011 BOTTLE in 1 CARTON (78307-100-01) > 120 mL in 1 BOTTLE1 bottle2020-07-030000-00-00NoNoCurrent