Ibuprofen

Product NDC
65162-672
11-digit product format
651620672
Labeler code
65162
Product ID
65162-672_010ab916-bc42-4e69-85d6-6585fc34226d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals
Application
ANDA200457
Marketing category
ANDA
Marketing start
2011-11-12
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-672-862019-11-13C16284748780-197449f38-b636-f6ea-e053-dbdaa90aa703Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/ Fever Reducer 100 mg/ 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-672-86IbuprofenPain Reliever/ Fever Reducer118 mL in 1 BOTTLESUSPENSION1184
65162-672-86IbuprofenPain Reliever/ Fever Reducer1 in 1 CARTONSUSPENSION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-672IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4Legacy NDC, 2 package rows20120222_ae1cb9ae-9d01-47f0-b9ec-0d924d913514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNae1cb9ae-9d01-47f0-b9ec-0d924d9135144
197803ibuprofen 20 MG/ML Oral SuspensionSCDae1cb9ae-9d01-47f0-b9ec-0d924d9135144
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYae1cb9ae-9d01-47f0-b9ec-0d924d9135144
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYae1cb9ae-9d01-47f0-b9ec-0d924d9135144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65162-672-8665162067286118 mL in 1 BOTTLE118 mlHistorical