FDA.reportPublic FDA data

Ibuprofen

Product NDC
51672-2130
11-digit product format
516722130
Labeler code
51672
Product ID
51672-2130_39623a94-8b73-17c6-e063-6294a90a4c31
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209207
Marketing category
ANDA
Marketing start
2017-06-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
51672-2130-1Ibuprofen1 in 1 CARTONSUSPENSION19
51672-2130-1Ibuprofen240 mL in 1 BOTTLESUSPENSION2409
51672-2130-8Ibuprofen1 in 1 CARTONSUSPENSION19
51672-2130-8Ibuprofen120 mL in 1 BOTTLESUSPENSION1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2130-1ML - Milliliter51672-2130ec8e73b1-094d-4ee4-9486-99c6adcfc94112017-12-14
51672-2130-8ML - Milliliter51672-213060e98840-aa05-4a38-8349-ef81b0bc4a3c12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2130IBUPROFEN SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 4 package rows20250406_f4dad3d6-1366-4bdf-99eb-370ab74a6b9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNf4dad3d6-1366-4bdf-99eb-370ab74a6b9e9
197803ibuprofen 20 MG/ML Oral SuspensionSCDf4dad3d6-1366-4bdf-99eb-370ab74a6b9e9
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYf4dad3d6-1366-4bdf-99eb-370ab74a6b9e9
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYf4dad3d6-1366-4bdf-99eb-370ab74a6b9e9
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN32edaf34-046e-4ded-8bee-493a0019d6bd5
197803ibuprofen 20 MG/ML Oral SuspensionSCD32edaf34-046e-4ded-8bee-493a0019d6bd5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY32edaf34-046e-4ded-8bee-493a0019d6bd5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY32edaf34-046e-4ded-8bee-493a0019d6bd5
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNb7565aac-a928-4116-b9af-cf636da4537c3
197803ibuprofen 20 MG/ML Oral SuspensionSCDb7565aac-a928-4116-b9af-cf636da4537c3
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYb7565aac-a928-4116-b9af-cf636da4537c3
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYb7565aac-a928-4116-b9af-cf636da4537c3
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNb87cf806-1635-44d5-a9de-383081cb37d81
197803ibuprofen 20 MG/ML Oral SuspensionSCDb87cf806-1635-44d5-a9de-383081cb37d81
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYb87cf806-1635-44d5-a9de-383081cb37d81
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYb87cf806-1635-44d5-a9de-383081cb37d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2130-1516722130011 BOTTLE in 1 CARTON (51672-2130-1) / 240 mL in 1 BOTTLE1 bottle2017-06-270000-00-00NoNoCurrent
51672-2130-8516722130081 BOTTLE in 1 CARTON (51672-2130-8) / 120 mL in 1 BOTTLE1 bottle2017-06-270000-00-00NoNoCurrent