FDA.reportPublic FDA data

Ibuprofen

Product NDC
10544-014
11-digit product format
105440014
Labeler code
10544
Product ID
10544-014_e4370315-e6c1-40b7-a529-33f79ff1d819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2010-09-08
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
10544-014-152019-10-29C16284748780-1960f7f55-d451-8e05-e053-dbdaa90a074aIbuprofen Tablets, USP
10544-014-202019-10-29C16284748780-1960f7f55-d451-8e05-e053-dbdaa90a074aIbuprofen Tablets, USP
10544-014-302019-10-29C16284748780-1960f7f55-d451-8e05-e053-dbdaa90a074aIbuprofen Tablets, USP
10544-014-402019-10-29C16284748780-1960f7f55-d451-8e05-e053-dbdaa90a074aIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-014-15Ibuprofen15 in 1 BOTTLETABLET152
10544-014-20Ibuprofen20 in 1 BOTTLETABLET202
10544-014-30Ibuprofen30 in 1 BOTTLETABLET302
10544-014-40Ibuprofen40 in 1 BOTTLETABLET402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-014-30EA - Each10544-0148588bba8-3866-45bd-b8bf-ceca91e05f4612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-014IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 4 package rows20101014_4b6d1f53-57c4-435a-ac4b-eb12c6cab62e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN4b6d1f53-57c4-435a-ac4b-eb12c6cab62e2
197806ibuprofen 600 MG Oral TabletSCD4b6d1f53-57c4-435a-ac4b-eb12c6cab62e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-014-151054400141515 in 1 BOTTLEHistorical
10544-014-201054400142020 in 1 BOTTLEHistorical
10544-014-301054400143030 in 1 BOTTLEHistorical
10544-014-401054400144040 in 1 BOTTLEHistorical