ibuprofen

Product NDC
10544-201
11-digit product format
105440201
Labeler code
10544
Product ID
10544-201_37a7a356-bd9e-4dd8-98cc-bd3650a09105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2014-02-04
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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
10544-201-402020-01-31C16284748780-19d75b9d1-0a23-f424-e053-dadaa90a57ce37a7a356-bd9e-4dd8-98cc-bd3650a09105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-201-40ibuprofen100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-201-40EA - Each10544-2016fd5d5a7-a873-4684-a344-eb97ff411c2612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1
ibuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN 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
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN 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
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
10544-201IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150305_37a7a356-bd9e-4dd8-98cc-bd3650a09105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN37a7a356-bd9e-4dd8-98cc-bd3650a091051
197806ibuprofen 600 MG Oral TabletPSN37a7a356-bd9e-4dd8-98cc-bd3650a091051
197807ibuprofen 800 MG Oral TabletPSN37a7a356-bd9e-4dd8-98cc-bd3650a091051
197805ibuprofen 400 MG Oral TabletSCD37a7a356-bd9e-4dd8-98cc-bd3650a091051
197806ibuprofen 600 MG Oral TabletSCD37a7a356-bd9e-4dd8-98cc-bd3650a091051
197807ibuprofen 800 MG Oral TabletSCD37a7a356-bd9e-4dd8-98cc-bd3650a091051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-201-4010544020140100 in 1 BOTTLEHistorical