FDA.reportPublic FDA data

Ibuprofen

Product NDC
10544-214
11-digit product format
105440214
Labeler code
10544
Product ID
10544-214_1360d60f-2459-734a-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2010-04-28
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
10544-214-002020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-152020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-202020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-302020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-402020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-602020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
10544-214-902020-01-31C16284748780-19d75b9d0-c95e-f424-e053-dadaa90a57ceIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-214-00Ibuprofen100 in 1 BOTTLETABLET1002
10544-214-15Ibuprofen15 in 1 BOTTLETABLET152
10544-214-20Ibuprofen20 in 1 BOTTLETABLET202
10544-214-30Ibuprofen30 in 1 BOTTLETABLET302
10544-214-40Ibuprofen40 in 1 BOTTLETABLET402
10544-214-60Ibuprofen60 in 1 BOTTLETABLET602
10544-214-90Ibuprofen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-214-20EA - Each10544-214f99d8915-33a5-4d0c-b471-2b98fb18f46a12015-02-02
10544-214-30EA - Each10544-21433fb70b2-9b7b-4276-87c9-c6651e9cbec112015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-214IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 7 package rows20150410_40c5dd26-8f05-41d9-aa21-f0713b2fbfe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN40c5dd26-8f05-41d9-aa21-f0713b2fbfe32
197806ibuprofen 600 MG Oral TabletSCD40c5dd26-8f05-41d9-aa21-f0713b2fbfe32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-214-0010544021400100 in 1 BOTTLEHistorical
10544-214-151054402141515 in 1 BOTTLEHistorical
10544-214-201054402142020 in 1 BOTTLEHistorical
10544-214-301054402143030 in 1 BOTTLEHistorical
10544-214-401054402144040 in 1 BOTTLEHistorical
10544-214-601054402146060 in 1 BOTTLEHistorical
10544-214-901054402149090 in 1 BOTTLEHistorical