Ibuprofen

Product NDC
10544-024
11-digit product format
105440024
Labeler code
10544
Product ID
10544-024_8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2010-11-03
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
10544-024-302020-01-31C16284748780-19d75b9d0-b32f-f424-e053-dadaa90a57ceIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-024-30Ibuprofen500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-024-30EA - Each10544-024a9e21ea6-580e-43cf-8e4f-adbef395246212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
BUTETH-3INACTIVE INGREDIENTOC116GRO69IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-024IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150307_8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11
197806ibuprofen 600 MG Oral TabletPSN8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11
197807ibuprofen 800 MG Oral TabletPSN8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11
197805ibuprofen 400 MG Oral TabletSCD8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11
197806ibuprofen 600 MG Oral TabletSCD8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11
197807ibuprofen 800 MG Oral TabletSCD8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-024-3010544002430500 in 1 BOTTLEHistorical