Childrens Ibuprofen

Product NDC
61269-761
11-digit product format
612690761
Labeler code
61269
Product ID
61269-761_d68ede64-6e42-42b2-b25e-4d3bfe1f0c1f
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
H2-Pharma, LLC
Application
ANDA074916
Marketing category
ANDA
Marketing start
2021-06-29
Marketing end
2023-04-30
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-761-94ML - Milliliter61269-761c4feb10d-1447-4bcc-9fbf-63cac5400eb012021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61269-761-94612690761941 BOTTLE in 1 CARTON (61269-761-94) > 118 mL in 1 BOTTLE1 bottle2021-06-290000-00-00NoNoCurrent