Ibuprofen

Product NDC
49035-716
11-digit product format
490350716
Labeler code
49035
Product ID
49035-716_eb420354-f305-4be1-bf99-9a715027591f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA074916
Marketing category
ANDA
Marketing start
2018-02-26
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-716-94ML - Milliliter49035-7162dbe8dbc-c2e9-42ed-9fd7-b78c422b651f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-716IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Legacy NDC20250305_54393cd5-4ed4-42dd-ac9b-7dc1ef7cfce3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-716-94490350716941 BOTTLE in 1 CARTON (49035-716-94) > 118 mL in 1 BOTTLE1 bottle2018-02-260000-00-00NoNoCurrent