FDA.reportPublic FDA data

Ibuprofen

Product NDC
51672-1409
11-digit product format
516721409
Labeler code
51672
Product ID
51672-1409_39624591-4c56-0f24-e063-6394a90ae7f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA209204
Marketing category
ANDA
Marketing start
2017-06-23
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-1409-82024-08-21C16284748780-11030e365-00f7-111a-e063-dadaa90a10e2Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-92024-08-21C16284748780-11030e365-00f7-111a-e063-dadaa90a10e2Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-82024-01-30C16284748780-11030e365-00f7-111a-e063-dadaa90a10e2Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-92024-01-30C16284748780-11030e365-00f7-111a-e063-dadaa90a10e2Ibuprofen Oral Suspension USP, 100 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1409-8Ibuprofen118 mL in 1 BOTTLESUSPENSION1187
51672-1409-8Ibuprofen1 in 1 CARTONSUSPENSION17
51672-1409-9Ibuprofen473 mL in 1 BOTTLESUSPENSION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1409-8ML - Milliliter51672-1409bdd82116-10dd-4cd6-bf89-d72a2fa262d912023-06-06
51672-1409-9ML - Milliliter51672-1409c7e52d12-ddb7-4336-889b-c29935981feb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1409IBUPROFEN SUSPENSION [-SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20250406_398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e7
197803ibuprofen 20 MG/ML Oral SuspensionSCD398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e7
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e7
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1409-8516721409081 BOTTLE in 1 CARTON (51672-1409-8) / 118 mL in 1 BOTTLE1 bottle2022-07-060000-00-00NoNoCurrent
51672-1409-951672140909473 mL in 1 BOTTLE (51672-1409-9) 473 ml2022-07-060000-00-00NoNoCurrent