equate ibuprofen

Product NDC
49035-166
11-digit product format
490350166
Labeler code
49035
Product ID
49035-166_bd06ac06-407e-460f-a2ce-71f903634e90
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-04-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equate ibuprofen
Brand name suffix
childrens
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-166-26equate ibuprofenchildrens118 mL in 1 BOTTLESUSPENSION1188
49035-166-26equate ibuprofenchildrens1 in 1 CARTONSUSPENSION18
49035-166-34equate ibuprofenchildrens237 mL in 1 BOTTLESUSPENSION2378
49035-166-34equate ibuprofenchildrens1 in 1 CARTONSUSPENSION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-166EQUATE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]7Current NDC, Legacy NDC, 4 package rows20250514_7817923f-4c21-4943-a7e2-dad4e2915fc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7817923f-4c21-4943-a7e2-dad4e2915fc48
197803ibuprofen 20 MG/ML Oral SuspensionSCD7817923f-4c21-4943-a7e2-dad4e2915fc48
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7817923f-4c21-4943-a7e2-dad4e2915fc48
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7817923f-4c21-4943-a7e2-dad4e2915fc48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-166-26490350166261 BOTTLE in 1 CARTON (49035-166-26) / 118 mL in 1 BOTTLE1 bottle2002-04-160000-00-00NoNoCurrent
49035-166-34490350166341 BOTTLE in 1 CARTON (49035-166-34) / 237 mL in 1 BOTTLE1 bottle2015-07-170000-00-00NoNoCurrent