Ibuprofen

Product NDC
67046-310
11-digit product format
670460310
Labeler code
67046
Product ID
67046-310_6f3018fb-cec9-4908-8c70-ceeedd7d240d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075682
Marketing category
ANDA
Marketing start
2009-09-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
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
67046-310-212019-10-21C16284748780-1956f9ecf-bcb5-621f-e053-dbdaa90a74adIbuprofen Tablets, USP
67046-310-302019-10-21C16284748780-1956f9ecf-bcb5-621f-e053-dbdaa90a74adIbuprofen Tablets, USP
67046-310-602019-10-21C16284748780-1956f9ecf-bcb5-621f-e053-dbdaa90a74adIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-310-21Ibuprofen21 in 1 BLISTER PACKTABLET211
67046-310-30Ibuprofen30 in 1 BLISTER PACKTABLET301
67046-310-60Ibuprofen60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-310IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 3 package rows20091006_cd638f0a-897b-494b-8182-2dc0d65e9fb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNcd638f0a-897b-494b-8182-2dc0d65e9fb21
197806ibuprofen 600 MG Oral TabletPSNcd638f0a-897b-494b-8182-2dc0d65e9fb21
197807ibuprofen 800 MG Oral TabletPSNcd638f0a-897b-494b-8182-2dc0d65e9fb21
197805ibuprofen 400 MG Oral TabletSCDcd638f0a-897b-494b-8182-2dc0d65e9fb21
197806ibuprofen 600 MG Oral TabletSCDcd638f0a-897b-494b-8182-2dc0d65e9fb21
197807ibuprofen 800 MG Oral TabletSCDcd638f0a-897b-494b-8182-2dc0d65e9fb21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-310-216704603102121 in 1 BLISTER PACKHistorical
67046-310-306704603103030 in 1 BLISTER PACKHistorical
67046-310-606704603106060 in 1 BLISTER PACKHistorical