FDA.reportPublic FDA data

IBUPROFEN

Product NDC
51672-2146
11-digit product format
516722146
Labeler code
51672
Product ID
51672-2146_4db5c2e1-85e1-4689-e063-6294a90aaf91
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA217261
Marketing category
ANDA
Marketing start
2023-08-08
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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
IBUPROFEN
Brand name suffix
Infants
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442

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
51672-2146-3IBUPROFENInfants30 mL in 1 BOTTLESUSPENSION/ DROPS306
51672-2146-3IBUPROFENInfants1 in 1 CARTONSUSPENSION/ DROPS16
51672-2146-5IBUPROFENInfants1 in 1 CARTONSUSPENSION/ DROPS16
51672-2146-5IBUPROFENInfants15 mL in 1 BOTTLESUSPENSION/ DROPS156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2146IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [-SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, 4 package rows20250406_bc816597-a85a-4143-9f99-bb0699ca57c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 40 MG/ML Oral SuspensionSCDbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYbc816597-a85a-4143-9f99-bb0699ca57c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2146-3516722146031 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLE1 bottle2023-08-08NoNoCurrent
51672-2146-5516722146051 BOTTLE in 1 CARTON (51672-2146-5) / 15 mL in 1 BOTTLE1 bottle2024-12-03NoNoCurrent