Ibuprofen Oral

Product NDC
63629-1230
11-digit product format
636291230
Labeler code
63629
Product ID
63629-1230_715f71f8-e3da-4ed2-a17e-728bde117b63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen Oral
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210602
Marketing category
ANDA
Marketing start
2018-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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
63629-1230-1ML - Milliliter63629-1230412aca40-f03c-433e-a3a9-1cfac30d4c1012021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1230-163629123001118 mL in 1 BOTTLE (63629-1230-1) 118 ml2021-02-110000-00-00NoNoCurrent